BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 5609571 · Received April 26, 2016

    Report

    Report Number
    1034569-2016-00086
    Event Type
    Malfunction
    Date Received
    April 26, 2016
    Date of Event
    February 29, 2016
    Report Date
    April 26, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707/5045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR'S PRODUCT INVESTIGATIONS LAB PERFORMED A SCREEN ASSAY ON CUSTOMER'S SUBMITTED SAMPLE ON THE ECHO USING RETENTION CAPTURE-R READY-SCREEN (3), LOT R708, AND CAPTURE-R READY INDICATOR RED CELL, LOT 221603. CONTROLS PERFORMED AS EXPECTED AND CUSTOMER'S SAMPLE RESULTED 4+ POSITIVE ON CELLS 1 AND 2 WHICH ARE D+ CELLS. CELL 3 RESULTED NEGATIVE (D NEG CELL). PI PERFORMED AN ANTIBODY ID ON CUSTOMER'S SUBMITTED SAMPLE ON THE ECHO USING RETENTION CAPTURE-R READY-ID, LOT ID294, AND CAPTURE-R READY INDICATOR RED CELL, LOT 221603. CONTROLS PERFORMED AS EXPECTED. CELLS 9, 10, AND 12 RESULTED EQUIVOCAL (PIN HOLES) CELLS 1-4, 13 AND 14 RESULTED POSITIVE, AND ALL OTHER CELLS RESULTED NEGATIVE. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE REACTIVITY ON A PATIENT SAMPLE CONTAINING ANTI-D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263398 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R708

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR