BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 5706291 · Received June 8, 2016

    Report

    Report Number
    1034569-2016-00130
    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 TECHNICAL SUPPORT PERFORMED A REMOTE REVIEW OF THE INSTRUMENT CAMERA IMAGES: BATCH (B)(4) TESTED ON (B)(6) 2016 USING LOTS R732 WITH 221623 NEGATIVE REACTIONS FOR CELLS 1 AND 2 VISUALLY NEGATIVE POSITIVE REACTION FOR CELL 3 AT 2+. THE PI LAB CONFIRMED THE REACTIVITY OF THE E ANTIGEN ON CELL 2 OF RETENTION CAPTURE-R READY-SCREEN (3), LOT R732, ON THE ECHO, USING RETENTION CAPTURE-R READY INDICATOR RED CELL, LOT 221635 AND ANTI-E, LOT BA631. CONTROLS PERFORMED AS EXPECTED AND ALL CELLS RESULTED AS EXPECTED. RETENTION PRODUCT PERFORMED AS EXPECTED. PI LAB PERFORMED A SCREEN ASSAY ON CUSTOMER'S RETURN SAMPLE, SAMPLE (B)(6) (PER CUSTOMER PATIENT HAS AN ANTI-E) 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 (E-) AND EQUIVOCAL (PIN HOLES) ON CELLS 1 (E-) AND 2 (E+). SAMPLE RETESTED USING THE SAME REAGENTS. CONTROLS PERFORMED AS EXPECTED. CUSTOMER'S SAMPLE RESULTED POSITIVE ON CELL 3 (E-), EQUIVOCAL (VISUALLY NEGATIVE) ON CELL 1 (E-), AND NEGATIVE ON CELL 2 (E+). 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-E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361289 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R732 10888234001454

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR