BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPHA SCREEN TEST CELLS

    MDR report key: 6592307 · Received May 25, 2017

    Report

    Report Number
    1034569-2017-00094
    Event Type
    Malfunction
    Date Received
    May 25, 2017
    Date of Event
    May 10, 2017
    Report Date
    May 15, 2017
    Manufacturer
    IMMUCOR, INC.
    Product Code
    MYR
    UDI-DI
    10888234001485
    PMA / PMN Number
    BK120021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMMUCOR REVIEW CONCLUDED THAT THE PROBABILITY OF OCCURRENCE OF HARM (POH) IS IMPROBABLE (B)(6). THE SEVERITY OF A TRANSFUSION TRANSMITTED (B)(6) IS CONSIDERED SERIOUS BECAUSE THE RESULTING INJURY (INFECTION) WOULD REQUIRE MEDICAL ATTENTION. THIS MDR IS LINKED TO (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2017, IMMUCOR DEEMED AN MDR REPORTABLE TO FDA, DUE THIRTY (30) DAYS FROM THE DATE OF (B)(6) 2017 FOR TPHA SCREEN TEST CELLS (LOT NUMBER 280006).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373969 TPHA SCREEN TEST CELLS FOR THE DETECTION OF ANTIBODIES TO TREPONEMA PALLIDUM MYR IMMUCOR, INC. 280006 10888234001485

    Patients

    Seq Age Sex Outcome Treatment
    1