BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITEK® 2 AST-GP75 TEST KIT

    MDR report key: 7089012 · Received December 6, 2017

    Report

    Report Number
    1950204-2017-00431
    Event Type
    Injury
    Date Received
    December 6, 2017
    Report Date
    May 11, 2018
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    PMA / PMN Number
    K053097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM THE UNITED STATES REPORTED TO BIOMÉRIEUX A FALSE RESISTANT RESULT ((B)(6)) FOR A STAPHYLOCOCCUS AUREUS BLOOD CULTURE ISOLATE FROM A PATIENT, IN ASSOCIATION WITH THE VITEK® 2 AST-GP75 TEST KIT. THE CUSTOMER DID NOT SUBMIT THE ISOLATE OR RAW DATA FOR EVALUATION. SUBMITTAL OF THE ISOLATE IS REQUIRED IN ORDER TO CONFIRM A VITEK 2 DISCREPANCY COMPARED TO THE REFERENCE METHOD. THE VITEK 2 RAW CARD DATA ARE REQUIRED IN ORDER TO ASSESS ORGANISM GROWTH IN THE CARD. THE AST-GP75 LOT # 2750438203 MET FINAL QC RELEASE CRITERIA AND PASSED INITIAL QC PERFORMANCE TESTING.

    Additional Manufacturer Narrative · 1

    TYPE OF REPORTABLE EVENT - MALFUNCTION, WAS INCORRECT IN REPORT 1950204-2017-00431 SUPPLEMENT 1 SUBMITTED ON 11MAY2018. THE CORRECT TYPE OF REPORTABLE EVENT IS SERIOUS INJURY.

    Description of Event or Problem · 1

    A CUSTOMER FROM THE UNITED STATES REPORTED TO BIOMÉRIEUX A FALSE RESISTANT RESULT (B)(6) FOR A (B)(6) BLOOD CULTURE ISOLATE FROM A PATIENT, IN ASSOCIATION WITH THE VITEK® 2 AST-GP75 TEST KIT. THE PATIENT WAS BEING TREATED WITH VANCOMYCIN AND OXACILLIN. THE ISOLATE WAS FIRST TESTED USING AN ALTERNATE METHOD, AND WAS IDENTIFIED AS (B)(6) . IN RESPONSE, VANCOMYCIN TREATMENT WAS STOPPED AND THE PATIENT CONTINUED WITH OXACILLIN. THE NEXT DAY, PB2 AND MECA TESTING WERE PERFORMED, AND BOTH RESULTS WERE NEGATIVE. THE ISOLATE WAS THEN TESTED WITH VITEK® 2 AST-GP75 WHEREAS, THE CEFOXITIN SCREEN WAS POSITIVE, THE OXACILLIN MIC WAS SENSITIVE, AND BETA LACTAMS WERE RESISTANT. A RESULT OF (B)(6) WAS REPORTED TO THE PHYSICIAN AND VANCOMYCIN TREATMENT WAS RESTARTED FOR THE PATIENT. THE ISOLATE WAS THEN RETESTED TWICE WITH AST-GP75 AND THE CEFOXITIN SCREEN WAS NEGATIVE AND THE OXACILLIN MIC WAS (B)(6). THE ISOLATE WAS SENT TO THE CDC AND IT WAS IDENTIFIED AS (B)(6) . 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
    868249 VITEK® 2 AST-GP75 TEST KIT VITEK® 2 AST-GP75 TEST KIT LON BIOMERIEUX, INC 2750438203

    Patients

    Seq Age Sex Outcome Treatment
    1 Other