BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-GP67 TEST KIT

    MDR report key: 8020613 · Received October 30, 2018

    Report

    Report Number
    1950204-2018-00452
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Report Date
    January 7, 2019
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    UDI-DI
    03573026242060
    PMA / PMN Number
    K053097
    Removal / Correction Number
    4018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR A CUSTOMER REPORTING THE OCCURRENCE OF FALSE NEGATIVE CEFOXITIN SCREEN (OXSF) FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH THE VITEK® 2 AST-GP67 TEST KIT USING V7.01 SOFTWARE. THE US CUSTOMER SUBMITTED TWO S. AUREUS ISOLATES FOR OXACILLIN/CEFOXITIN SCREEN (OX/OXSF) EVALUATION. SINCE OX MICS=1 FOR BOTH ISOLATES, THE CUSTOMER WAS ALERTED VIA FSCA 4018, AND STRAINS WERE SUBMITTED FOR FURTHER TESTING. IDENTIFICATION OF THE ORGANISMS WAS CONFIRMED, AND TESTING INCLUDED TWO CUSTOMER LOTS (1320760213 AND 1320718203) AND A RANDOM LOT (1320697203) OF AST-GP67 CARDS, RUN ON V7.01 AND V8.01 SOFTWARE. AGAR DILUTION (AD), THE REFERENCE METHOD FOR OX TESTING, WAS PERFORMED, AS WAS FOX DISK TESTING, THE REFERENCE METHOD FOR THE OXSF TEST. ALERE PBP2A TESTING WAS ALSO PERFORMED. ISOLATE 911790 ("NOSE"): WHEN TESTED IN V7.01, SUSCEPTIBLE OX MICS=1AND NEGATIVE OXSF RESULTS WERE OBTAINED ON ALL THREE CARD LOTS. WHEN TESTED IN V8.01, SUSCEPTIBLE OX MICS=0.5 WERE OBTAINED ON TWO OF THREE CARDS; ON THE THIRD CARD, A RESISTANT MIC>=4 WAS OBTAINED. OXSF WAS POSITIVE FOR ALL THREE CARD RUNS. OX AD GAVE A SUSCEPTIBLE MIC=1. THESE RESULTS ARE IN AGREEMENT WITH FIVE OF THE SIX CARDS TESTED, WHERE MICS=0.5 OR 1 WERE OBTAINED. THE ONE CARD GIVING AN OX MIC>=4 IS AN ESSENTIAL AGREEMENT ERROR AND MAJOR ERROR FOR THE VITEK 2. FOX DISK TESTING WAS POSITIVE (17 MM), AS WAS PBP2A TESTING. THEREFORE, THE POSITIVE OXSF RESULTS OBTAINED IN V8.01 ARE IN AGREEMENT WITH REFERENCE METHOD TESTING; HOWEVER, THE FALSE NEGATIVE OXSF RESULTS OBTAINED BY THE CUSTOMER WERE REPRODUCED WHEN TESTED IN V7.01. ISOLATE 911791 ("GROIN"): WHEN TESTED IN V7.01, SUSCEPTIBLE OX MICS=0.5 OR 1 WERE OBTAINED, AND OXSF RESULTS WERE NEGATIVE. WHEN TESTED IN V8.01, OX MICS=0.5 OR 1 WERE OBTAINED, AND OXSF RESULTS WERE POSITIVE. OX AD GAVE A SUSCEPTIBLE MIC=1, SO CARDS AND REFERENCE METHOD ARE IN AGREEMENT FOR THIS DRUG. FOX DISK TESTING WAS POSITIVE (18 MM), AS WAS PBP2A TESTING. THEREFORE, THE POSITIVE OXSF RESULTS OBTAINED IN V8.01 ARE IN AGREEMENT WITH REFERENCE METHOD TESTING; HOWEVER, THE FALSE NEGATIVE OXSF RESULTS OBTAINED BY THE CUSTOMER WERE REPRODUCED WHEN TESTED IN V7.01. NOTE: FIELD SAFETY CORRECTIVE ACTION 4018 WAS ISSUED 21AUG2018, IN WHICH BIOMÉRIEUX RECOMMENDS ACTIONS TO FURTHER AID IN MITIGATING POTENTIAL NON-DETECTION OF MRSA WHEN TESTING OXACILLIN (OX) AND CEFOXITIN SCREEN (OXSF) ON VITEK 2.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT THE OCCURRENCE OF (B)(6) CEFOXITIN SCREEN (OXSF) FOR (B)(6) IN ASSOCIATION WITH THE VITEK® 2 AST-GP67 TEST KIT. (B)(6) SOURCE - NOSE. CEFOXITIN SCREEN NEGATIVE. (B)(6). ALTERNATE METHOD (B)(6) RESULT (RESISTANT). THE CUSTOMER STATED NO INCORRECT RESULTS WERE RELEASED TO THE PHYSICIAN AND NO PATIENT TREATMENT WAS IMPACTED OR DELAYED. THE DISCREPANT RESULT DID NOT LEAD TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOMÉRIEUX REQUESTED STRAIN SUBMITTAL FROM THE CUSTOMER. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862538 VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-GP67 TEST KIT VITEK® 2 AST-GP67 CARD LON BIOMERIEUX, INC 1320760213 03573026242060

    Patients

    Seq Age Sex Outcome Treatment
    1