BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-ID

    MDR report key: 5199429 · Received November 3, 2015

    Report

    Report Number
    1034569-2015-00165
    Event Type
    Malfunction
    Date Received
    November 3, 2015
    Date of Event
    October 6, 2015
    Report Date
    November 3, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEWED BATCH IMAGES: A SYNOPSIS OF TESTING ON SAMPLE ID: X5844 ON CRRID BATCH (B)(4) USING CRRID LOT ID270 AND INDICATOR CELL LOT 221477 IS AS FOLLOWS: (B)(6). UNEXPECTED NEGATIVE REACTIVITY IS NOTED FOR E POSITIVE CELLS 1, 3 AND 6 FOR CRRID BATCH (B)(4). SEROLOGICAL EVALUATION: THE PI LAB CONFIRMED THE REACTIVITY OF THE E ANTIGEN ON CELLS 1, 3, AND 6 OF RETENTION CRRID LOT ID270 IN MANUAL CAPTURE RETENTION CAPTURE-R INDICATOR CELL 221494 WITH RETENTION ANTI-E LOT BA631 (1:1 DILUTION). CONTROLS PERFORMED AS EXPECTED. POSITIVE RESULTS EXHIBITED 2-4+ REACTIVITY. RETENTION PRODUCT PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS UNEXPECTED NEGATIVE REACTIVITY WHEN TESTING A PATIENT SAMPLE WITH A KNOWN ANTI-E WITH CAPTURE-R READY-ID (CRRID) LOT ID270 AND CAPTURE-R READY-ID EXTEND I LOT DP081 ON THE GALILEO ECHO INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729297 CAPTURE-R READY-ID REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. ID270

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR