BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANOSCREEN I II & III

    MDR report key: 1061904 · Received June 20, 2008

    Report

    Report Number
    1034569-2008-00198
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 22, 2008
    Report Date
    June 18, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Removal / Correction Number
    FA 08-03
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CELL III OF PANOSCREEN LOT 13604 WAS OBSERVED TO BE DARKER IN APPEARANCE DURING INSPECTION OF THE RETENTION SAMPLES. THE COMPLAINT WAS CONFIRMED. LOT 13604 WAS RECALLED ON 4/30/08. THE PACKAGE INSERT INDICATES, "REAGENT RED BLOOD CELLS SHOULD NOT BE USED IF THE CELLS DARKEN, SPONTANEOUSLY CLUMP OR IF THERE IS SIGNIFICANT HEMOLYSIS." AN UNEXPECTED POSITIVE REACTION WOULD LEAD TO ADDITIONAL TESTING AND WOULD NOT HAVE NEGATIVE IMPACT ON PATIENT TESTING OTHER THAN A CONFUSING SEROLOGICAL REACTION. AN UNEXPECTED NEGATIVE COULD LEAD TO A MISSED ANTIBODY AND THE SUBSEQUENT TRANSFUSION OF INCOMPATIBLE BLOOD.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT CELL III IN PANOSCREEN I, II, III IS VERY DARK IN COLOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PANOSCREEN I II & III REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. 13604

    Patients

    Seq Age Sex Outcome Treatment
    1