BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 ANC TEST KIT

    MDR report key: 7038388 · Received November 16, 2017

    Report

    Report Number
    1950204-2017-00402
    Event Type
    Malfunction
    Date Received
    November 16, 2017
    Report Date
    February 6, 2018
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    JSP
    UDI-DI
    03573026144364
    PMA / PMN Number
    K910666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) HAD NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION RESULTS FOR BACTEROIDES FRAGILIS ATCC25285 STRAIN IN ASSOCIATION WITH VITEK® 2 ANC TEST KIT (REF 21347). THE STRAIN WAS TESTED THREE TIMES WITH VITEK® 2, WHICH PROVIDED THE FOLLOWING IDENTIFICATIONS: FIRST TEST: BACTEROIDES STERCORIS 95%. SECOND TEST: PREVOTELLA BIVIA 95%. THIRD TEST: BACTEROIDES STERCORIS 95%. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS COMPLETED. THE INTENDED IDENTIFICATION OF BACTEROIDES FRAGILIS WAS CONFIRMED ON VITEK MS V3 (KNOWLEDGE BASE V3.0). ON VITEK 2 (V7.01) ANC CARDS, ONE (1) CARD OF THE CUSTOMER LOT (CL : 2440318203) AND ONE (1) CARD OF A RANDOM LOT (RL : 2440320203) WERE TESTED FROM CBA SUBCULTURE. THESE TESTS GAVE AN EXCELLENT IDENTIFICATION TO B. FRAGILIS ON BOTH LOTS. THE CUSTOMER MISIDENTIFICATION WAS NOT DUPLICATED IN-HOUSE. THE VITEK 2 ANC CARD PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION RESULTS FOR BACTEROIDES FRAGILIS (B)(4) STRAIN IN ASSOCIATION WITH VITEK® 2 ANC TEST KIT (REF 21347). THE STRAIN WAS TESTED THREE TIMES WITH VITEK® 2, WHICH PROVIDED THE FOLLOWING IDENTIFICATIONS: FIRST TEST: BACTEROIDES STERCORIS 95%. SECOND TEST: PREVOTELLA BIVIA 95%. THIRD TEST: BACTEROIDES STERCORIS 95%. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT ASSOCIATED WITH THIS QC STRAIN. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816536 VITEK® 2 ANC TEST KIT VITEK® 2 ANC TEST CARD JSP BIOMERIEUX, INC 2440318203 03573026144364

    Patients

    Seq Age Sex Outcome Treatment
    1