BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY ID

    MDR report key: 1079964 · Received July 24, 2008

    Report

    Report Number
    1034569-2008-00260
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 24, 2008
    Report Date
    July 8, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE ADDITIONAL DETAILS. THE CAPTURE-R POSITIVE CONTROL LOT 243029 (WELL 1-8 AND 15) AND CAPTURE R NEGTIVE CONTROL LOT 241022 (WELL 9-13 AND 16) WERE TESTED WITH RETENTION CRRID LOT ID071. THE EXPECTED REACTIVITY WAS OBSERVED. THE CUSTOMER DID NOT RETURN PRODUCT OR SAMPLE FOR INVESTIGATION. IT IS NOT POSSIBLE TO RULE OUT THE SAMPLE AS A CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WITH CAPTURE-R READY ID ON A PATIENT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY ID REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. ID071

    Patients

    Seq Age Sex Outcome Treatment
    1