BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (POOLED CELLS)

    MDR report key: 8903339 · Received August 16, 2019

    Report

    Report Number
    1034569-2019-00129
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    July 4, 2019
    Report Date
    August 16, 2019
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001317
    PMA / PMN Number
    102707/0.0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2019 IMMUCOR CONFIRMED THE PRESENCE OF THE DIA ANTIGEN ON RETENTION CAPTURE-R READY-SCREEN (POOLED CELLS) LOT NUMBER B045 IN MANUAL CAPTURE USING RETENTION CAPTURE-R INDICATOR CELL LOT NUMBER 221369 WITH RETENTION ANTI-DIA LOT NUMBER DIA081910DE. CONTROLS PERFORMED AS EXPECTED. CAPTURE-R READY-SCREEN (POOLED CELLS) LOT NUMBER B045, CELL 1 DI(A+), RESULTED POSITIVE AS EXPECTED. RETENTION PRODUCT PERFORMED AS EXPECTED. 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 REPORTED AN UNEXPECTED NEGATIVE RESULT WITH CAPTURE-R READY-SCREEN (POOLED CELLS) ON A GALILEO NEO INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695249 CAPTURE-R READY-SCREEN (POOLED CELLS) AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC. B045 10888234001317

    Patients

    Seq Age Sex Outcome Treatment
    1