BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-D (MONOCLONAL BLEND) SERIES 5

    MDR report key: 840089 · Received February 22, 2007

    Report

    Report Number
    1034569-2007-00037
    Event Type
    Malfunction
    Date Received
    February 22, 2007
    Date of Event
    January 22, 2007
    Report Date
    February 21, 2007
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    103523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT AND SAMPLE WERE NOT RETURNED FOR INVESTIGATION TESTING. THE CUSTOMER SENT THE SAMPLE TO ANOTHER FACILITY FOR TESTING AND THE TESTING FACILITY REPORTED THE BLOOD TYPE AS O, RH POSITIVE. USER ERROR CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED POSITIVE REACTIVITY (2+) AT THE IMMEDIATE SPIN PHASE (IS) WITH ANTI-D (MONOCLONAL BLEND) SERIES 5, ON A PREVIOUSLY TYPED RH NEGATIVE PT SAMPLE. THE FIRST SAMPLE FROM THE PT TYPED AS O, RH NEGATIVE ON 01/2007. A SECOND SAMPLE TYPED AS O, RH NEGATIVE THREE DAYS LATER. A RECHECK WAS PERFORMED ON THE SECOND SAMPLE AND IT TESTED AS O, RH POSITIVE. REPEAT TESTING ON THE FIRST SAMPLE ALSO RESULTED AS O, RH POSITIVE. A THIRD SAMPLE WAS COLLECTED THE FOLLOWING DAY, AND ALSO TYPED AS O, RH POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-D (MONOCLONAL BLEND) SERIES 5 BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. * 505545

    Patients

    Seq Age Sex Outcome Treatment
    1 *