BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 5706298 · Received June 8, 2016

    Report

    Report Number
    1034569-2016-00131
    Event Type
    Malfunction
    Date Received
    June 8, 2016
    Date of Event
    May 10, 2016
    Report Date
    June 7, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001454
    PMA / PMN Number
    102707/0.0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHINCAL SUPPORT PERFORMED A REMOTE REVIEW OF THE INSTRUMENT CAMERA IMAGES: BATCH (B)(4). SAMPLE ID (B)(6) CELL 1: (NEG) VISUALLY NEG, CELL 2: (NEG) VISUALLY NEG, CELL 3: (NEG) VISUALLY NEG CELL II IS (S+,S-), CELL III (S+,S+). PI LAB CONFIRMED THE REACTIVITY OF THE S ANTIGENS ON CELLS 2 AND 3 OF RETENTION CAPTURE-R READY-SCREEN (3), LOT R732, ON THE ECHO, USING RETENTION CAPTURE-R READY INDICATOR RED CELL, LOT 221635 AND ANTI-S, LOT 4 2ML. CONTROLS PERFORMED AS EXPECTED. CELL 1 RESULTED EQUIVOCAL (PINHOLES). REPEATED TESTING, USING THE SAME LOTS OF REAGENT. CONTROLS PERFORMED AS EXPECTED AND CELL 1 RESULTED NEGATIVE AS EXPECTED. RETENTION PRODUCT PERFORMED AS EXPECTED. PI LAB PERFORMED A SCREEN ASSAY ON RETURN SAMPLE, SAMPLE (B)(6) (PER CUSTOMER IS S+), ON THE ECHO, USING RETENTION CAPTURE-R READY-SCREEN (3), LOT R732 AND CAPTURE-R READY INDICATOR RED CELL, LOT 221635. CONTROLS PERFORMED AS EXPECTED. CUSTOMER'S SAMPLE RESULTED POSITIVE ON CELL 3 (S+) AND NEGATIVE ON CELLS 1 (S-) AND 2 (S+). WE WERE ABLE TO REPRODUCE CUSTOMER'S OBSERVATION WITH SUBMITTED SAMPLE WITH CELL 2, BUT NOT CELL 3. WE WERE ABLE TO REPRODUCE CUSTOMER'S OBSERVATION WITH SUBMITTED SAMPLE. THIS ISSUE APPEARS TO BE UNIQUE TO THE SAMPLE.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY SCREENS WHEN USING CAPTURE-R READY-SCREEN (3) (CRRS 3) ON A GALILEO ECHO INSTRUMENT. THE SAMPLE CONTAINS AN ANTI-S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361291 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R732 10888234001454

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR