BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN 3

    MDR report key: 8640102 · Received May 24, 2019

    Report

    Report Number
    1034569-2019-00102
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Date of Event
    April 19, 2019
    Report Date
    May 24, 2019
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001461
    PMA / PMN Number
    102707/5045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON APRIL 30, 2019 IMMUCOR TESTED SAMPLE ID (B)(4) USING RETENTION CAPTURE-R READY-SCREEN 3 LOT NUMBER E331 (EXPIRY APRIL 30, 2019) USING CAPTURE-R READY INDICATOR RED CELLS LOT NUMBER 221302 ON THE GALILEO NEO INSTRUMENT SERIAL NUMBER (B)(4); SAMPLE REACTED EQUIVOCAL WITH CELL 1 (24,9) AND 3 (25,1). KNOWN IN-HOUSE SAMPLES WERE RUN WITH THE CUSTOMER SAMPLE; THE 2 KNOWN NEGATIVE IN-HOUSE DONOR SAMPLES REACTED NEGATIVE AS EXPECTED AND THE 2 KNOWN ANTI-E POSITIVE IN-HOUSE SAMPLE REACTED POSITIVE AS EXPECTED. RETENTION PRODUCT PERFORMED AS EXPECTED WITH ALL IN-HOUSE SAMPLES. CUSTOMER ISSUE WAS DETERMINED TO BE SAMPLE-RELATED (ANTIBODIES PRESENT IN CONCENTRATIONS TOO LOW TO BE DETECTED BY THE TEST METHODS EMPLOYED). THE IMMUCOR INTERNAL REPORT RECORD NUMBER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2019 A CUSTOMER IN (B)(6) REPORTED UNEXPECTED NEGATIVE ANTIBODY SCREEN RESULTS WITH CAPTURE-R READY-SCREEN 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434556 CAPTURE-R READY-SCREEN 3 REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. E331 10888234001461

    Patients

    Seq Age Sex Outcome Treatment
    1