BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-ID

    MDR report key: 6057846 · Received October 26, 2016

    Report

    Report Number
    1034569-2016-00274
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    September 29, 2016
    Report Date
    October 26, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001140
    PMA / PMN Number
    102707/0.0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SYNOPSIS OF THE TESTING FOR CRRID BATCH 618 FOR SAMPLE (B)(6) USING CRRID LOT ID311 WITH CELL LOT 221707 IS AS FOLLOWS: (B)(6). CONTROL WELLS REACTED AS EXPECTED. UNEXPECTED NEGATIVE REACTIVITY IS NOTED FOR CELLS 1, 2, 3, 5, 6, 7, 9, AND 12. CONFIRMED THE REACTIVITY OF THE FYA AND E ANTIGEN ON RETENTION CAPTURE-R READY-ID, LOT ID311, IN MANUAL CAPTURE, USING RETENTION CAPTURE-R READY INDICATOR RED CELL, LOT 221709, ANTI-FYA (1:16 DILUTION), AND ANTI-E, LOT TN0034-B (1:16 DILUTION). CONTROLS PERFORMED AS EXPECTED AND ALL CELLS TESTED, EXHIBITED THE EXPECTED REACTIVITY. RETENTION PERFORMED AS EXPECTED. A SERVICE CALL WAS MADE AND THE INSTRUMENT IS OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WHEN TESTING PATIENT SAMPLE (B)(6) WITH CAPTURE-R READY-ID ON THE GALILEO ECHO INSTRUMENT. SAMPLE IS KNOWN TO CONTAIN AN ANTI-FYA. NO ADVERSE EVENT OCCURRED. TESTING WAS FOR VALIDATION PURPOSES ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709923 CAPTURE-R READY-ID REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. ID311 10888234001140

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR