BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-P612 TEST KIT

    MDR report key: 6633385 · Received June 12, 2017

    Report

    Report Number
    1950204-2017-00187
    Event Type
    Malfunction
    Date Received
    June 12, 2017
    Report Date
    December 20, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    PMA / PMN Number
    K053097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX A FALSE SUSCEPTIBLE CEFOXITIN RESULT FOR A STAPHYLOCOCCUS AUREUS ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-P612 TEST KIT. THE CUSTOMER SUBMITTED THE ISOLATE FOR EVALUATION. AN INVESTIGATION WAS PERFORMED. THE SUBMITTED STRAIN WAS SUBCULTURED, AND THE IDENTIFICATIONS WAS CONFIRMED AS S. AUREUS. VITEK 2 TESTING INCLUDED THE AST-P612 CARDS FROM THE CUSTOMER'S AND A RANDOM LOT, IN DUPLICATE. AGAR DILUTION (AD), THE REFERENCE METHOD FOR OX (OX101N) WAS PERFORMED, AS WAS FOX DISC TESTING AS THE REFERENCE METHOD FOR THE OXSF TEST, AND PBP2A LATEX TESTING. 911453 (162860269): THREE AST-P612 CARDS TESTED RESULTED IN OX MICS = 1.0 WHILE THE REMAINING CARD OX MIC = 0.5. ALL FOUR CARDS WERE OXSF NEGATIVE. AD MIC = 4. CARD AND REFERENCE METHOD MICS ARE MORE THAN 1 DOUBLING DILUTIONS APART MAKING THIS AN ESSENTIAL AGREEMENT ERROR FOR THE VITEK 2. THE RESISTANT CEFOXITIN DISC (18 MM) AND THE POSITIVE PBP2A LATEX TESTING DEMONSTRATE THE CARD OXFS CALLS OF NEGATIVE TO BE INCORRECT. NOTE: THE RAW DATA FROM THE INTERNAL TESTING OF THIS S. AUREUS ISOLATE WAS ANALYZED WITH THE MODIFIED OXSF01N KNOWLEDGE BASE (V8.01), AND ALL FOUR REPLICATES WERE POSITIVE. WHEN TESTING THIS ISOLATE AGAINST THE CEFOXITIN DISC, SMALL COLONIES WERE VISIBLE IN THE ZONE OF INHIBITION. THESE INDUCED COLONIES WERE SUBCULTURED AND TESTING INCLUDED THE CUSTOMER LOT AND A RANDOM LOT OF AST-P612 CARDS, IN DUPLICATE. THE FOUR ADDITIONAL CARDS TESTED RESULTED IN OX MICS >/= 4 AND POSITIVE OXFS TESTS SO CARDS ARE IN ESSENTIAL AGREEMENT WITH THE REFERENCE METHOD FOR OX AND OXFS, WITH NO CATEGORY ERROR AFTER INDUCTION. THIS STRAIN DEMONSTRATES HETEROGENEOUS RESISTANCE.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX A FALSE SUSCEPTIBLE CEFOXITIN RESULT FOR A STAPHYLOCOCCUS AUREUS ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-P612 TEST KIT. THE CUSTOMER REPORTED THAT THEY HAD TWO PATIENTS IN WHICH THE STAPHYLOCOCCUS AUREUS ISOLATE TESTED OXACILLIN SUSCEPTIBLE AND CEFOXITIN NEGATIVE. WHEN THESE ISOLATES WERE CHECKED BY DISC METHOD (CDS), CEFOXITIN WAS RESISTANT (<6MM) AND PBP 2A WAS POSITIVE FOR MECA GENE. THE CUSTOMER REPORTED: PATIENT 1: PBP2A TEST WAS POSITIVE. UPON GETTING A NEGATIVE VITEK® 2 RESULT, CDS WAS PERFORMED WHICH WAS RESISTANT TO OX AND CEFOXITIN . THE VITEK® 2 GPS WAS ALSO REPEATED AND WAS OX=NEG. THE ISOLATE WAS SENT TO AN EXTERNAL LAB FOR MECA PCR WHICH TESTED AS POSITIVE. SO IT WAS A TRUE (B)(6). PATIENT 2: TWO COLONY TYPES WERE TESTED. ONE TESTED OX=R BY VITEK® 2 AND WAS PBP2A POSITIVE. THE SECOND TESTED OX=S BY VITEK® 2 AND PBP2A POSITIVE. CDS WAS PERFORMED ON BOTH WHICH WHERE OX AND FOX RESISTANT. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX 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
    414171 VITEK® 2 AST-P612 TEST KIT VITEK® 2 AST-P612 TEST CARD LON BIOMERIEUX, INC 4920046403

    Patients

    Seq Age Sex Outcome Treatment
    1