BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-GP67 TEST KIT

    MDR report key: 8206481 · Received December 31, 2018

    Report

    Report Number
    1950204-2018-00735
    Event Type
    Malfunction
    Date Received
    December 31, 2018
    Report Date
    February 27, 2019
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    UDI-DI
    03573026242060
    PMA / PMN Number
    K053097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED FOR A CUSTOMER REPORT OF INITIAL AND REPEAT FALSE SUSCEPTIBLE OXACILLIN (OX) (MIC= 0.5) AND FALSE NEGATIVE CEFOXITIN SCREEN (OXSF) RESULTS WITH A STAPHYLOCOCCUS AUREUS STRAIN USING THE VITEK® 2 AST-GP67 CARD, LOT 1320816203 (WITH VITEK 2 8.01 SOFTWARE). THE CUSTOMER WAS VALIDATING THEIR PBP2A KIT, AND THIS STRAIN WAS POSITIVE. THE STRAIN WAS THEN SENT OUT TO ARUP FOR CONFIRMATORY TESTING AND WAS DETERMINED TO BE MRSA (OXACILLIN MIC=4, PBP2A POSITIVE). THE SUBMITTED STRAIN WAS SUBCULTURED AND IDENTIFICATION CONFIRMED AS S. AUREUS. FURTHER TESTING INCLUDED VITEK 2 AST-GP67 CARDS FROM THE CUSTOMER'S LOT (1320816203) AND A RANDOM LOT (1320760203), AGAR DILUTION (AD) AND CEFOXITIN DISK DIFFUSION AS THE REFERENCE METHODS FOR OX101N AND OXSF101N FORMULATIONS FOUND ON THIS CARD, AS WELL AS ALERE PBP2. VITEK 2 TESTING WAS PERFORMED WITH SOFTWARE V8.01. 911825 (6118005291): OX MIC=1 AND </= 0.25 WITH NEGATIVE OXSF RESULTS. OX AD MIC = 0.5 AND CEFOXITIN DISK DIFFUSION WAS SUSCEPTIBLE (24MM). PBP2A WAS POSITIVE. WHILE THE CUSTOMER'S RESULTS WERE REPRODUCED, VITEK 2 OX AND OXSF TESTING ARE IN ESSENTIAL AGREEMENT WITH THEIR REFERENCE METHODS. THE VITEK 2 CARDS ARE PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF THE NON-DETECTION OF AN (B)(6) STRAIN WHEN TESTING THE STAPHYLOCOCCUS AUREUS STRAIN, OBTAINED FROM A URINE SAMPLE, WITH THE VITEK® 2 AST-GP67 TEST KIT. THE (B)(6) MIC OBTAINED WAS (B)(6). THE CEFOXITIN SCREEN WAS NEGATIVE. THE CUSTOMER WAS VALIDATING THEIR PBP2A KIT, AND IT OBTAINED AN (B)(6) RESULT. THE STRAIN WAS SENT TO A REFERENCE LAB AND DETERMINED TO BE (B)(6). THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046267 VITEK® 2 AST-GP67 TEST KIT VITEK® 2 AST-GP67 TEST KIT LON BIOMERIEUX, INC. 1320816203 03573026242060

    Patients

    Seq Age Sex Outcome Treatment
    1