BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK 2 AST-GP67 TEST KIT

    MDR report key: 9820672 · Received March 11, 2020

    Report

    Report Number
    1950204-2020-00058
    Event Type
    Malfunction
    Date Received
    March 11, 2020
    Report Date
    May 1, 2020
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    UDI-DI
    03573026242060
    PMA / PMN Number
    K053097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS INITIATED IN RESPONSE TO A CUSTOMER COMPLAINT OF A FALSE POSITIVE CEFOXITIN SCREEN RESULT FOR A PATIENT STAPHYLOCOCCUS AUREUS ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-GP67 TEST KIT (REF. (B)(4), LOT 1321260213). THE ISOLATE OBTAINED A POSITIVE CEFOXITIN SCREEN RESULT WITH A SUSCEPTIBLE OXACILLIN RESULT THAT WAS MODIFIED TO RESISTANT BY THE ADVANCED EXPERT SYSTEM (AES). THE CUSTOMER SUBMITTED THE STRAIN FOR INVESTIGATIONAL TESTING. THE CUSTOMER¿S ISOLATE WAS RECEIVED AND SUB-CULTURED TO REMEL TSAB AT 35-37C IN CO2 FOR 22 HOURS. AFTER A SECOND SUB-CULTURE, THE ISOLATE WAS TESTED WITH CARDS FROM THE CUSTOMER¿S LOT (1321260213) AND A RANDOM LOT (1321123103), BOTH IN DUPLICATE. REFERENCE METHOD AND ALTERNATIVE TESTS INCLUDED OXACILLIN AGAR DILUTION, CEFOXITIN DISC DIFFUSION AND PBP2A. THE IDENTIFICATION OF THE ISOLATE WAS CONFIRMED ON VITEK® MS AS STAPHYLOCOCCUS AUREUS. 912252: ALL FOUR CARDS RETURNED NEGATIVE CEFOXITIN SCREEN AND SUSCEPTIBLE OXACILLIN (MIC = 0.5 MG/L) RESULTS. REFERENCE METHOD AND ALTERNATIVE TESTING YIELDED THE FOLLOWING RESULTS: OXACILLIN AGAR DILUTION: MIC = 0.5 MG/L (SUSCEPTIBLE). CEFOXITIN DISC DIFFUSION: 23 MM (SUSCEPTIBLE). PBP2A: NEG. THE CUSTOMER¿S FALSE POSITIVE CEFOXITIN SCREEN WAS NOT REPRODUCED AND THE VITEK 2 CARDS ARE PERFORMING AS INTENDED. AST-GP67, LOT 1321260213 MET FINAL QC RELEASE CRITERIA. THE LOT PASSED QC PERFORMANCE TESTING.SEE H10 FOR ADDTL MFG NARRATIVE.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED SATES NOTIFIED BIOMÉRIEUX OF A FALSE POSITIVE CEFOXITIN SCREEN RESULT FOR A PATIENT STAPHYLOCOCCUS AUREUS ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-GP67 TEST KIT (REF. 22226, LOT 1321260213). THE ISOLATE OBTAINED A POSITIVE CEFOXITIN SCREEN RESULT WITH A SUSCEPTIBLE OXACILLIN RESULT THAT WAS MODIFIED TO RESISTANT BY THE ADVANCED EXPERT SYSTEM (AES). THE ISOLATE WAS RETESTED ON THE VITEK® 2 AND USING THE MECA TEST METHOD; BOTH ASSAYS OBTAINED A NEGATIVE RESULT. THE CUSTOMER CONFIRMED THE POSITIVE CEFOXITIN SCREEN RESULT WAS REPORTED TO THE TREATING PHYSICIAN. HOWEVER, THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT HARM OR INCORRECT TREATMENT DUE TO THE DISCREPANT RESULT. NOTE: CUSTOMER REPORT HAD A COMMENT ENABLED STATING ¿IF CEFOXITIN SCREEN IS POSITIVE AND OXACILLIN RESULT IS SUSCEPTIBLE: RECHECK ID AND CONFIRM PURITY ¿ REPEAT TESTING ¿ IF STILL INCONSISTENT, CONFIRM WITH MECA TEST BEFORE REPORTING.¿ BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283545 VITEK 2 AST-GP67 TEST KIT VITEK® 2 AST-GP67 TEST KIT LON BIOMERIEUX, INC 1321260213 03573026242060

    Patients

    Seq Age Sex Outcome Treatment
    1