BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-ID EXTEND I

    MDR report key: 5304093 · Received December 16, 2015

    Report

    Report Number
    1034569-2015-00212
    Event Type
    Malfunction
    Date Received
    December 16, 2015
    Date of Event
    November 20, 2015
    Report Date
    December 16, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707/0.0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE CUSTOMER'S INSTRUMENT IMAGE RESULT FILES SHOWED ALL WELLS OF CAPTURE-R READY EXTEND I LOT DP082 RESULTED NEGATIVE ON BATCH (B)(4). PI LAB CONFIRMED THE REACTIVITY OF THE E ANTIGEN ON RETENTION CAPTURE-R READY EXTEND I, LOT DP082, USING THE ECHO, WITH RETENTION CAPTURE-R READY INDICATOR RED CELL, LOT 221510 AND ANTI-E, LOT DL20750. CONTROLS PERFORMED AS EXPECTED AND ALL REAGENT CELLS EXHIBITED THE EXPECTED REACTIVITY. PERFORMED AN ANTIBODY ID ON CUSTOMER'S SUBMITTED SAMPLE, (B)(4), IN MANUAL CAPTURE, USING CELLS 8-14 OF RETENTION CAPTURE-R READY-ID EXTEND I, LOT DP082 WITH RETENTION CAPTURE-R READY INDICATOR RED CELL, LOT 221512. CONTROLS PERFORMED AS EXPECTED AND ALL CELLS (E+), TESTED, EXHIBITED NEGATIVE REACTIVITY. WE WERE ABLE TO REPRODUCE CUSTOMER'S OBSERVATION WITH SUBMITTED SAMPLE. OUR FINDINGS CONFIRM THAT CELLS 8-14 OF CAPTURE-R READY-ID EXTEND I, LOT DP082 ARE E+ AND ARE AVAILABLE FOR ANTIGEN-ANTIBODY REACTION. THE UNEXPECTED REACTIVITY APPEARS TO BE UNIQUE TO THE NATURE OF THE CUSTOMER'S SAMPLE.

    Description of Event or Problem · 1

    REPORT OF UNEXPECTED NEGATIVE REACTIVITY WHEN TESTING A PATIENT SAMPLE WITH A KNOWN ANTI-E WITH CAPTURE-R READY-ID EXTEND I LOT DP082 ON THE GALILEO ECHO. NO ADVERSE EVENTS OCCURRED AS A RESULT OF THE UNEXPECTED NEGATIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832187 CAPTURE-R READY-ID EXTEND I REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. DP082

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR