BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT

    MDR report key: 5070222 · Received September 11, 2015

    Report

    Report Number
    1950204-2015-00028
    Event Type
    Malfunction
    Date Received
    September 11, 2015
    Report Date
    September 3, 2015
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LQL
    PMA / PMN Number
    K952095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX INTERNAL INVESTIGATION WAS INITIATED. THE PATIENT ISOLATE WAS REQUESTED BY BIOMÉRIEUX: HOWEVER, THE CUSTOMER DID NOT COMPLY WITH THE SUBMITTAL REQUEST. NO ORGANISM RECEIVED. REVIEW OF QC BATCH RECORDS FOR THE IDENTIFIED VITEK® 2 GP ID CARD LOT INDICATED THE LOT PASSED ON INITIAL QC TESTING. THERE WERE NO ATYPICAL RESULTS OBSERVED WITH QC PERFORMANCE TESTING. NO FURTHER INVESTIGATION IS POSSIBLE.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED A DISCREPANT ORGANISM IDENTIFICATION ON THE VITEK 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT (REF 21342, LOT 242351310). THE GP ID ORGANISM WAS REPORTED AS ENTEROCOCCUS CASSELIFLAVUS / ENTEROCOCCUS GALLINARUM. THE PATIENT ISOLATE WAS ALSO TESTED ON THE VITEK MS FOR CONFIRMATORY TESTING; A RESULT OF ENTEROCOCCUS FAECIUM WAS OBTAINED. REPEAT TESTING USING THE GP ID TEST KIT AGAIN PROVIDED A RESULT OF ENTEROCOCCUS CASSELIFLAVUS / ENTEROCOCCUS GALLINARUM. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMERIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. CULTURE SUBMITTALS HAVE BEEN REQUESTED BY BIOMERIEUX FOR INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602983 VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT VITEK® 2 GP ID CARD LQL BIOMERIEUX, INC 242351310

    Patients

    Seq Age Sex Outcome Treatment
    1