BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-ID

    MDR report key: 4632400 · Received March 25, 2015

    Report

    Report Number
    1034569-2015-00048
    Event Type
    Malfunction
    Date Received
    March 25, 2015
    Date of Event
    February 25, 2015
    Report Date
    March 24, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PI LAB CONFIRMED THE REACTIVITY OF THE E ANTIGEN ON CAPTURE-R READY-ID, LOTS ID242. CONTROLS PERFORMED AS EXPECTED. ALL REAGENT CELLS EXHIBITED THE EXPECTED REACTIVITY. PI PERFORMED AN ANTIBODY ID ASSAY ON CUSTOMER'S SUBMITTED SAMPLES, 10251087 B AND 10251087 C, ON THE ECHO USING RETENTION CAPTURE-R READY-ID, LOT ID242 AND CAPTURE-R READY INDICATOR RED CELL, 221327. CONTROLS PERFORMED AS EXPECTED AND BOTH SAMPLES RESULTED NEGATIVE.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WHEN TESTING A PATIENT SAMPLE WITH CAPTURE-R READY ID ON THE ECHO INSTRUMENT. THE SAMPLE CONTAINED ANTI-E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200904 CAPTURE-R READY-ID REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. ID242

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR