BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY ID

    MDR report key: 1070873 · Received July 9, 2008

    Report

    Report Number
    1034569-2008-00225
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 27, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE REACTIVITY OF THE C ANTIGEN WAS CONFIRMED ON RETENTION CRRID, LOT ID099. 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. THE ANTIBODY APPEARS TO BE AT THE LIMIT OF DETECTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WITH CAPTURE-R READY ID (CRRID) TEST WELLS. ANTI-C WAS NOT DETECTED IN A PATIENT SAMPLE IN SCREENING AND IDENTIFICATION ASSAYS ON GALILEO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY ID REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. ID099

    Patients

    Seq Age Sex Outcome Treatment
    1