BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-GP75 TEST KIT

    MDR report key: 7265050 · Received February 12, 2018

    Report

    Report Number
    1950204-2018-00069
    Event Type
    Malfunction
    Date Received
    February 12, 2018
    Report Date
    March 23, 2018
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    PMA / PMN Number
    N50510: S117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM THE UNITED STATES HAD REPORTED TO BIOMÉRIEUX A FALSE SUSCEPTIBLE OXACILLIN RESULT FOR STAPHYLOCOCCUS AUREUS ((B)(6)), IN ASSOCIATION WITH THE VITEK® 2 AST-GP75 TEST KIT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED USING THE ISOLATES SUBMITTED BY THE CUSTOMER. BOTH ISOLATES WERE TESTED ON THE CUSTOMER LOT AND A RANDOM LOT OF AST-GP75 CARDS. AGAR DILUTION (AD), THE REFERENCE METHOD FOR OX (OXACILLIN) WAS PERFORMED, AS WAS FOX DISC TESTING (REFERENCE METHOD FOR THE CEFOXITIN SCREEN TEST - OXFS TEST) AND PBP2A LATEX TESTING. ISOLATE 911514: OX MICS WERE 0.5 OR 1 ON CARD RUNS, BUT WERE CORRECTED TO RESISTANT BY AES DUE TO POSITIVE OXFS RESULTS OBTAINED ON BOTH CARD RUNS. AD FOR OX GAVE A RESISTANT MIC=8. THOUGH THIS IS AN ESSENTIAL AGREEMENT ERROR, THE RESISTANT VITEK 2 RESULTS DO CORRELATE WITH THE RESISTANT OX AD RESULTS. POSITIVE RESULTS WERE OBTAINED WITH FOX DISC TESTING AND PBP2A LATEX TESTING, CONFIRMING THE OXFS VITEK 2 RESULTS TO BE CORRECT. ISOLATE 911515: OX WAS SUSCEPTIBLE ON BOTH CARD RUNS (MIC=0.5). AD GAVE A SUSCEPTIBLE OX MIC=2. THOUGH THERE IS CATEGORY AGREEMENT, CARD AND REFERENCE METHOD MICS ARE MORE THAN 1 DOUBLING DILUTION APART, WHICH IS AN ESSENTIAL AGREEMENT ERROR FOR THE VITEK 2. OXFS WAS NEGATIVE ON BOTH CARD RUNS. FOX DISC TESTING WAS POSITIVE (16 MM) AND PBP2 LATEX TESTING WAS ALSO POSITIVE, DEMONSTRATING THAT THE OXFS NEGATIVE CALL ON THE CARDS IS INCORRECT. THE RAW DATA FROM THE INTERNAL TESTING OF S. AUREUS WAS ANALYZED WITH THE NEW OXSF01N KNOWLEDGE BASE (V8.01), AND ALL RUNS WERE POSITIVE. THESE ARE ATYPICAL ISOLATES.

    Description of Event or Problem · 1

    A CUSTOMER FROM THE UNITED STATES REPORTED (B)(6), IN ASSOCIATION WITH THE VITEK® 2 AST-GP75 TEST KIT. THE ISOLATE WAS FROM A BLOOD CULTURE, FROM A (B)(6) MALE WITH DIABETES MELLITUS ON INSULIN AND ANTIBIOTICS. THE CUSTOMER REPORTED THAT THE STRAIN WAS (B)(6) WHEN TESTED WITH THE AST-GP75 CARD. THE RESULTS WERE (B)(6), ONLY FOR CLINDAMYCIN AND ERYTHROMYCIN. REPEAT TESTING WITH THE AST-GP75 CARD WAS PERFORMED WITH A SECOND BLOOD CULTURE (COLLECTED A DAY LATER), AND THE RESULT WAS A (B)(6). THE RESULTS FOR BOTH THE PBP2 TEST AND CHROMID® MRSA WERE (B)(6), CONFIRMING (B)(6). THE CUSTOMER STATED THE INCORRECT AST-GP75 CARD RESULT WAS REPORTED TO THE TREATING PHYSICIAN, WHO WAS IN THE TESTING LAB AT THE TIME AND AWARE OF THE DISCREPANCY. THE CUSTOMER REPORTED THERE WAS NO IMPACT TO PATIENT TREATMENT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108442 VITEK® 2 AST-GP75 TEST KIT VITEK® 2 AST-GP75 TEST KIT LON BIOMERIEUX, INC 2750487203

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR