BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 5183519 · Received October 28, 2015

    Report

    Report Number
    1034569-2015-00162
    Event Type
    Malfunction
    Date Received
    October 28, 2015
    Date of Event
    September 29, 2015
    Report Date
    October 26, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CAPTURE-R READY INDICATOR CELLS, LOT 221471, EXPIRED PRIOR TO BEING ABLE TO BEGIN THIS INVESTIGATION. HOWEVER, ON (B)(6) 2015 THE PI LAB PERFORMED A 3_CELL QC AND AN ANTIBODY SCREEN ON THE ECHO WITH FOUR KNOWN NEGATIVE IN HOUSE DONOR SAMPLES USING RETENTION CAPTURE-R INDICATOR CELLS LOT 221471 AND RETENTION CAPTURE-R READY SCREEN (3) PLATES LOT R661. CONTROLS PERFORMED AS EXPECTED AND ALL IN HOUSE DONOR SAMPLES WERE NEGATIVE AS EXPECTED. WBCORQC PERFORMED AS EXPECTED FOR ALL THREE LEVELS. RETENTION PRODUCT PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT UNEXPECTED NEGATIVE RESULTS WERE OBTAINED WITH THE ANTIBODY SCREENING ASSAY FOR A PATIENT SAMPLE WITH A HISTORY OF HAVING ANTI-K, ANTI-S, ANTI-FYB, ANTI-JKA, AND A LOW-INCIDENCE ANTI-S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715485 CAPTURE-R READY INDICATOR RED CELLS ANTI-IGG COATED RED BLOOD CELLS KSZ IMMUCOR, INC. 221471

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR