BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-ID

    MDR report key: 5086695 · Received September 18, 2015

    Report

    Report Number
    1034569-2015-00136
    Event Type
    Malfunction
    Date Received
    September 18, 2015
    Date of Event
    August 19, 2015
    Report Date
    September 17, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PI LAB CONFIRMED THE REACTIVITY OF THE E ANTIGEN, IN MANUAL CAPTURE, USING CELLS 1, 3, AND 6 OF RETENTION CAPTURE-R READY-ID, LOT ID270 WITH RETENTION CAPTURE-R READY INDICATOR RED CELL, LOT 221457 AND RETENTION ANTI-E, LOT 8A631-1-A (1:128 DILUTION). CONTROLS PERFORMED AS EXPECTED AND ALL REAGENT RED CELLS TESTED, EXHIBITED THE EXPECTED REACTIVITY. RETENTION PRODUCT PERFORMED AS EXPECTED. PI LAB CONFIRMED THE REACTIVITY OF THE E ANTIGEN ON CELLS 1, 3, AND 6 OF RETURNED CAPTURE-R READY-ID PLATE, LOT ID270 IN MANUAL CAPTURE USING RETENTION CAPTURE-R READY INDICATOR RED CELL, LOT 221460 AND RETENTION ANTI-E, LOT 8A631-1-A DILUTED 1:128. CONTROLS PERFORMED AS EXPECTED AND ALL REAGENT RED CELLS TESTED EXHIBITED THE EXPECTED REACTIVITY. RETURNED PRODUCT PERFORMED AS EXPECTED. OUR INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WHEN TESTING A PATIENT SAMPLE USING CAPTURE-R READY-ID (CRRID) ON THE GALILEO ECHO INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619884 CAPTURE-R READY-ID REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. ID270

    Patients

    Seq Age Sex Outcome Treatment
    1