BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-GP67 TEST KIT

    MDR report key: 9417527 · Received December 5, 2019

    Report

    Report Number
    1950204-2019-00324
    Event Type
    Malfunction
    Date Received
    December 5, 2019
    Report Date
    January 2, 2020
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    UDI-DI
    03573026242060
    PMA / PMN Number
    K053097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS COMPLETED IN RESPONSE TO A CUSTOMER COMPLAINT FOR FALSE POSITIVE CEFOXITIN SCREEN RESULTS FOR A STAPHYLOCOCCUS AUREUS ATCC® 29213¿ STRAIN IN ASSOCIATION WITH THE VITEK® 2 AST-GP67 TEST KIT (REF 22226, LOT 1321079103). THE INVESTIGATION ALSO INCLUDED LOT 1321211203, RELATED TO ANOTHER COMPLAINT FROM THE SAME CUSTOMER. INVESTIGATIONAL TESTING INCLUDED BOTH THE CUSTOMER'S STAPHYLOCOCCUS AUREUS ATCC® 29213¿ STRAIN AS WELL AS AN INTERNAL BIOMÉRIEUX STAPHYLOCOCCUS AUREUS ATCC® 29213¿ STRAIN. BOTH STRAINS WERE TESTED ON THE CUSTOMER'S LOTS (1321211203, 1321079103) AND A RANDOM LOT (1321123103) IN DUPLICATE. CUSTOMER'S STRAIN: ALL SIX (6) AST-GP67 CARDS TESTED OBTAINED THE EXPECTED NEGATIVE CEFOXITIN SCREEN RESULTS. BIOMÉRIEUX STRAIN: ALL SIX (6) AST-GP67 CARDS TESTED OBTAINED THE EXPECTED NEGATIVE CEFOXITIN SCREEN RESULTS. A REVIEW OF COMPLAINTS RELATED TO THE LOTS USED IN THE INVESTIGATION DID NOT INDICATE A TREND FOR THESE LOTS. AST-GP67 LOTS 1321079103, 1320596203 AND 1321211203 MET FINAL QC RELEASE CRITERIA. THESE LOTS PASSED QC PERFORMANCE TESTING. THE CUSTOMER'S FALSE POSITIVE CEFOXITIN SCREEN RESULTS WERE NOT REPRODUCED INTERNALLY AND THE VITEK® 2 AST-GP67 TEST KIT CARDS ARE PERFORMING AS EXPECTED.SEE H10 FOR ADDTL MFG NARRATIVE

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE CEFOXITIN SCREEN RESULTS FOR A STAPHYLOCOCCUS AUREUS ATCC® 29213¿ ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-GP67 TEST KIT (REF 22226, LOT 1320596203). THE STRAIN WAS TESTED BY MICROBIOLOGICS, INC WITH ANOTHER LOT OF THE VITEK® 2 AST-GP67 TEST KIT AND OBTAINED THE EXPECTED NEGATIVE CEFOXITIN SCREEN RESULT. AS THIS WAS A QC STRAIN, THERE WAS NO PATIENT INVOLVED. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211276 VITEK® 2 AST-GP67 TEST KIT AST-GP67 TEST KIT 20 CARDS - 22226 LON BIOMERIEUX, INC. 1320596203 03573026242060

    Patients

    Seq Age Sex Outcome Treatment
    1