BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 NH ID TEST KIT

    MDR report key: 6322068 · Received February 10, 2017

    Report

    Report Number
    1950204-2017-00051
    Event Type
    Malfunction
    Date Received
    February 10, 2017
    Report Date
    April 19, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    JST
    PMA / PMN Number
    CL 1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER REPORTED A MISIDENTIFICATION OF (B)(6) ON THE VITEK® 2 NH ID TEST CARD THE ISOLATE AND NH ID CARDS WERE SUBMITTED BY THE CUSTOMER FOR EVALUATION. AN INVESTIGATION WAS CONDUCTED. THE ISOLATE WAS SUBCULTURED ON CHOCOLATE MEDIUM. ONE (1) VITEK® 2 NH CARD FROM THE CUSTOMER LOT (2450061203) AND ONE (1) NH CARD FROM A RANDOM LOT (245381020) WERE TESTED. THE RESULTS WERE COMPARED WITH THOSE FROM FULL 16S SEQUENCING, VITEK® MS AND API NH STRIP TEST. THE REFERENCE METHOD (SEQUENCING FULL 16S) WAS USED TO DETERMINE THE INTENDED RESULT. VITEK® MS AND API NH STRIP WERE IN FAVOR OF THE SPECIES (B)(6). ON VITEK® 2, THE NH CARD FOR BOTH LOTS, GAVE AN EXCELLENT IDENTIFICATION TO THE SPECIES (B)(6). IN CONCLUSION, THE CUSTOMER RESULT WAS NOT REPRODUCED. THE VITEK® 2 NH ID CARDS PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION IN ASSOCIATION WITH THE VITEK 2 NH ID TEST KIT. THE URETERAL SAMPLE IS FROM A (B)(6) PATIENT WITH NO ANTIBIOTHERAPY. THE STRAIN WAS ISOLATED FROM CHOCOLATE AGAR AND TESTED THREE TIMES WITH VITEK 2 NH ID WHICH IDENTIFIED THE ISOLATE AS OF (B)(6). THE (B)(6) IDENTIFICATION WAS OBTAINED BY PCR AND MASS SPECTROMETRY IN ANOTHER LABORATORY. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. THE CUSTOMER DID REPORT A DELAY IN REPORTING RESULTS BY A "FEW DAYS." THE TEST REPORTS WERE REQUESTED FROM THE CUSTOMER. AN INTERNAL BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104340 VITEK® 2 NH ID TEST KIT VITEK® 2 NH ID TEST KIT JST BIOMERIEUX, INC 2450061203

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR