URGENT FIELD SAFETY NOTICE FSCA3303. ETEST XM256 (Cefuroxime) Foam (Ref , ) and SPB (Ref , )

Transcription

1 23 Jan 2017 URGENT FIELD SAFETY NOTICE FSCA3303 ETEST XM256 (Cefurxime) Fam (Ref , ) and SPB (Ref , ) Dear Custmer Our recrds indicate that yur labratry has received the fllwing prducts. This letter is intended fr all ETEST XM256 (Cefurxime) Fam (Ref , ) and SPB (Ref , ) users (prduct reference and lt numbers included belw). Prduct References impacted: Reference Descriptin Lt Number Expiry date ETEST XM256 (Cefurxime) US SPB Dec ETEST XM256 (Cefurxime) WW SPB Jan ETEST XM256 (Cefurxime) WW SPB Mar ETEST XM256 (Cefurxime) WW SPB Apr ETEST XM256 (Cefurxime) WW SPB Aug ETEST XM256 (Cefurxime) WW SPB May ETEST XM256 (Cefurxime) WW SPB Dec ETEST XM256 (Cefurxime) WW SPB Sep ETEST XM256 (Cefurxime) WW Fam Jan ETEST XM256 (Cefurxime) WW Fam Mar ETEST XM256 (Cefurxime) WW Fam Apr ETEST XM256 (Cefurxime) WW Fam Aug ETEST XM256 (Cefurxime) WW Fam Sep ETEST XM256 (Cefurxime) WW Fam May ETEST XM256 (Cefurxime) WW Fam Dec ETEST XM256 (Cefurxime) WW Fam Sep ETEST XM256 (Cefurxime) US Fam Jan ETEST XM256 (Cefurxime) US Fam Apr ETEST XM256 (Cefurxime) US Fam Sep ETEST XM256 (Cefurxime) US Fam May ETEST XM256 (Cefurxime) US Fam Dec ETEST XM256 (Cefurxime) US Fam Sep-19 Registered Office: Registered in England N

2 Descriptin f the issue An analysis was perfrmed n the Essential Agreement rate reflecting the MIC result btained by the prduct fr a significant strains kit including Enterbacteriaceae, Haemphilus and S. pneumniae. Species. Then, an additinal analysis was dne n the clinical categrizatin f the strains based n CLSI guidance. The fllwing have been identified: The investigatin cnfirmed a ptential perfrmance issue n strains categrizatin fr Streptcccus pneumniae and fr Enterbacteriaceae strains limited t ral cefurxim breakpints and based n 2016 CLSI clinical standards nly: Fr Streptcccus pneumniae n ETEST XM256 (Cefurxime) FOAM and SPB that culd lead t minr errr n clinical strains : False Susceptible result instead f Intermediate results with BMD (Brth Micr Dilutin) reference methd False Intermediate result instead f Resistant results with BMD reference methd Fr Enterbacteriaceae n ETEST XM256 (Cefurxime) FOAM and SPB that culd lead t minr errr n clinical strains: False Susceptible result instead f Intermediate results with AD (Agar Dilutin) reference methd False Intermediate result instead f Resistant results with AD reference methd Prducts perfrm within the specificatin when using the 2016 EUCAST guidelines. Impact t Patient/User: As the result f the referenced issue, the ptential hazard is t btain Minr errr (Susceptible instead f Intermediate r Intermediate instead f Resistant) n strain categrizatin fr Streptcccus pneumniae and fr Enterbacteriaceae strains nly when using the 2016 CLSI clinical breakpints defined fr cefurxime ral frms. Fr Streptcccus pneumniae strains and nly when ral breakpints are used (nt parenteral breakpints) fr Cefurxime: based n 2016 clinical CLSI guidelines, a reduced MIC value culd be btained with ETEST XM256 SPB and FOAM packaging that culd lead t a susceptible categrizatin instead f intermediate categrizatin (Minr Errr) r intermediate categrizatin instead f resistant Registered Office: Registered in England N

3 categrizatin (minr Errr) fr clinical strains cmpared t brth micrdilutin (BMD) reference methd. Fr Enterbacteriaceae strains and nly when ral breakpints are used (nt parenteral breakpints) fr Cefurxime: based n 2016 CLSI clinical guidelines, a reduced MIC value culd be btained with ETEST XM256 SPB and FOAM that culd lead t a susceptible categrizatin instead f intermediate categrizatin (Minr Errr) r intermediate categrizatin instead f resistant categrizatin (minr Errr) fr clinical strains cmpared t Agar dilutin (AD) reference methd Cnt. Registered Office: Registered in England N

4 Required actins: Please distribute this infrmatin t all apprpriate persnnel in yur labratry, retain a cpy in yur files, and frward this infrmatin t all parties that may use this prduct, including thers t whm yu may have transferred ur prduct. Recmmendatins nly fr users under 2016 CLSI clinical guidelines,: Labratries can cntinue t use ETEST XM256 SPB and FOAM and can directly reprt the results fr Streptcccus pneumniae and Enterbacteriaeceae when ral breakpints are used when applying the fllwing recmmendatins: Cefurxime ral breakpints Streptcccus pneumniae Cefurxime Results can be directly reprted fr Enterbacteriaceae Cefurxime Results can be directly reprted fr Islate tests penicillin susceptible (MIC 0.06 μg/ml) and cefurxime susceptible (ETEST XM256 MIC 1 μg /ml) Islate tests cefazlin (*) susceptible (MIC 16 μg/ml) and cefurxime susceptible (ETEST XM256 MIC 4 μg /ml) Islate tests penicillin resistant (MIC 0.12 μg/ml) and cefurxime resistant (ETEST XM256 4 μg /ml) Islate tests cefurxime resistant (ETEST XM μg /ml) Islate tests cefurxime resistant (ETEST XM256 4 μg /ml) the cefurxime MIC shuld be cnfirmed using an alternative MIC test methd fr the cefurxime MIC shuld be cnfirmed using an alternative MIC test methd fr islates testing penicillin resistant (MIC 0.12 μg/ml) and cefurxime susceptible (ETEST XM256 MIC 1μg/ml) r intermediate (ETEST XM256 MIC = 2μg/ml), islates testing cefazlin resistant (MIC 32 μg/ml) and cefurxime susceptible (ETEST XM256 MIC 4μg/ml) r intermediate (ETEST XM256 MIC = 8 r 16 μg/ml) (*) cmment 19 f page 55 f CLSI M100 S Registered Office: Registered in England N

5 Amng tests previusly perfrmed, we are asking yu t identify any pssible false Susceptible results, analyze the related risks and determine apprpriate actins if relevant. Cntact yur lcal bimérieux representative fr prduct cmpensatin. Cmplete and return the Acknwledgement Frm in Attachment A by Fax t cnfirm receipt f this ntice. bimérieux is cmmitted t prviding ur custmers with the highest quality prduct pssible. We sincerely aplgize fr any incnvenience that this may have caused yu. If yu require additinal assistance r have any questins, please cntact yur lcal bimérieux Custmer Service representative. Yurs sincerely, Custmer Service Registered Office: Registered in England N

6 Attachment A: Acknwledgement Frm FSCA3303 In rder t cmply with Cmpetent Authrity Regulatins it is imprtant that yu cmplete and return this acknwledgement frm Please return fr the attentin f Custmer Service t fax number 0044 (0) I acknwledge the receipt f bimérieux Urgent Field Safety Ntice infrming this labratry n the ETEST XM256 (Cefurxime) Fam (Ref , ) and SPB (Ref , ) prduct issue. Reference Descriptin Lt Number Expiry date ETEST XM256 (Cefurxime) US SPB Dec ETEST XM256 (Cefurxime) WW SPB Jan ETEST XM256 (Cefurxime) WW SPB Mar ETEST XM256 (Cefurxime) WW SPB Apr ETEST XM256 (Cefurxime) WW SPB Aug ETEST XM256 (Cefurxime) WW SPB May ETEST XM256 (Cefurxime) WW SPB Dec ETEST XM256 (Cefurxime) WW SPB Sep ETEST XM256 (Cefurxime) WW Fam Jan ETEST XM256 (Cefurxime) WW Fam Mar ETEST XM256 (Cefurxime) WW Fam Apr ETEST XM256 (Cefurxime) WW Fam Aug ETEST XM256 (Cefurxime) WW Fam Sep ETEST XM256 (Cefurxime) WW Fam May ETEST XM256 (Cefurxime) WW Fam Dec ETEST XM256 (Cefurxime) WW Fam Sep ETEST XM256 (Cefurxime) US Fam Jan ETEST XM256 (Cefurxime) US Fam Apr ETEST XM256 (Cefurxime) US Fam Sep ETEST XM256 (Cefurxime) US Fam May ETEST XM256 (Cefurxime) US Fam Dec ETEST XM256 (Cefurxime) US Fam Sep-19 Number f kits received Number f kits destryed Registered Office: Registered in England N

7 I have fllwed the instructins and implemented the actins as indicated in the Urgent Field Safety Ntice. Have yu received reprts f illness r injury related t the identified issue? Yes r N NAME:... DATE... SIGNATURE :... Registered Office: Registered in England N