BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 5180989 · Received October 27, 2015

    Report

    Report Number
    1034569-2015-00161
    Event Type
    Malfunction
    Date Received
    October 27, 2015
    Date of Event
    September 30, 2015
    Report Date
    October 26, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707/5045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMMUCOR PI LAB CONFIRMED THE PRESENCE OF THE S ANTIGEN ON CELLS 2 AND 3 OF RETENTION CAPTURE-R READY SCREEN (3) PLATES LOT R662 USING RETENTION CAPTURE-R INDICATOR CELLS LOT 221473 AND RETENTION ANTI-S LOT SC69N-1 DILUTED 1:18. CONTROLS PERFORMED AS EXPECTED AND CELLS 2 AND 3 WERE POSITIVE AS EXPECTED. RETENTION PRODUCT PERFORMED AS EXPECTED. AN ANTIBODY SCREEN WAS PERFORMED ON THE ECHO WITH THE CUSTOMERS RETURNED SAMPLE USING RETENTION CAPTURE-R READY SCREEN (3) PLATES LOT R662 AND RETENTION CAPTURE-R INDICATOR CELLS LOT 221473. CUSTOMERS RETURNED SAMPLE RESULTED AS NEGATIVE. ALL CELLS WERE VISUALLY NEGATIVE. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (3) ON A GALILEO ECHO INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711871 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R662

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR