BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-GP78 TEST KIT

    MDR report key: 7945102 · Received October 8, 2018

    Report

    Report Number
    1950204-2018-00412
    Event Type
    Malfunction
    Date Received
    October 8, 2018
    Report Date
    December 11, 2018
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    UDI-DI
    03573026553982
    PMA / PMN Number
    K053097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A US CUSTOMER NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE CEFOXITIN SCREEN (OXSF) AND SUSCEPTIBLE OXACILLIN (OX) MICS = 2 FOR A S. AUREUS ISOLATE AND VITEK 2 AST-GP78 CARD WITH SOFTWARE V07.01. THE RESULT WAS CONFIRMED AS MRSA BY CEPHEID, POSITIVE FOR MECA. THE STRAIN WAS SUBMITTED FOR INVESTIGATION. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: THE SUBMITTED STRAIN WAS SUBCULTURED, IDENTIFICATION CONFIRMED AS S. AUREUS, AND TESTING INCLUDED AST-GP78 CARDS FROM THE CUSTOMER'S LOT (2780684403)AND A RANDOM LOT (2780523203) AS WELL AS AGAR DILUTION (AD) AS THE REFERENCE METHOD FOR OX, CEFOXITIN DISK DIFFUSION AS THE REFERENCE METHOD FOR OXSF TEST AND PBP2A. TESTING WAS PERFORMED WITH VITEK 2 SOFTWARE V7.01 AND V8.01. EXPER/ESSAY 5492/212 911732 (F49309): WHEN TESTING WITH VITEK 2 SOFTWARE VERSION 7.01, OX MICS = 2 AND1 AND NEGATIVE OXSF RESULTS WERE OBTAINED, DUPLICATING THE CUSTOMER'S RESULTS. TESTING WITH SOFTWARE VERSION 8.01 OX MICS = 1 AND POSITIVE OXSF RESULTS WERE OBTAINED RESULTING IN AES MODIFICATION OF OX TO RESISTANT AND THE DETECTION OF MRSA. OX AD MIC = 0.5 AND PBP2A WAS POSITIVE. THE CEFOXITIN DISK DIFFUSION WAS RESISTANT (16 MM) NOTE: THE CUSTOMER'S RESULTS WOULD HAVE TRIGGERED THE BIOART RULE AS DESCRIBED IN FSCA 4018 ALERTING THE USER WITH FURTHER INSTRUCTION PER THEIR LABORATORY PRACTICES.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES REPORTED A (B)(6) CEFOXITIN SCREEN FOR A (B)(6) (ATCC® 29213) QUALITY CONTROL STRAIN WHEN USING THE VTEK® 2 AST-GP78 TEST KIT (LOT 2780684403). THE ISOLATE WAS TESTED TWICE AND THE CEFOXITIN SCREEN WAS (B)(6) WITH (B)(6). THE PCR CEPHEID RESULTED IN (B)(6). A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784356 VITEK® 2 AST-GP78 TEST KIT VITEK® 2 AST-GP78 TEST KIT LON BIOMERIEUX, INC. 2780684403 03573026553982

    Patients

    Seq Age Sex Outcome Treatment
    1