BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPHA SCREEN TEST CELLS

    MDR report key: 5971028 · Received September 22, 2016

    Report

    Report Number
    1034569-2016-00248
    Event Type
    Malfunction
    Date Received
    September 22, 2016
    Date of Event
    June 22, 2016
    Report Date
    September 22, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    MYR
    UDI-DI
    10888234001485
    PMA / PMN Number
    BK120021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT ASSESSED THE TEST WELL IMAGES ON THE TESTING INSTRUMENT USING A REMOTE ELECTRONIC CONNECTION METHOD ON (B)(6) 2016. THE TEST WELLS WERE VISUALLY NEGATIVE. THE IMMUCOR LABORATORY TESTED RETENTION PRODUCT ON (B)(6) 2016, WHICH PERFORMED AS EXPECTED. ADDITIONAL TESTING WAS PERFORMED USING THE RESEARCH USE ONLY SERACARE PANEL, WHICH YIELDED INCONSISTENT RESULTS, WHICH REPRODUCED THE CUSTOMER'S OBSERVATION.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A CUSTOMER REPORTED UNEXPECTED NEGATIVE OUTCOMES WHEN VALIDATING AN INSTRUMENT ASSAY FOR TPHA ASSAY, USING TPHA SCREEN TEST CELLS ON A GALILEO NEO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623572 TPHA SCREEN TEST CELLS FOR THE DETECTION OF ANTIBODIES TO TREPONEMA PALLIDUM MYR IMMUCOR, INC. 280006 10888234001485

    Patients

    Seq Age Sex Outcome Treatment
    1