BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 5353772 · Received January 8, 2016

    Report

    Report Number
    1034569-2016-00003
    Event Type
    Malfunction
    Date Received
    January 8, 2016
    Date of Event
    December 9, 2015
    Report Date
    January 8, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707/5045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMMUCOR PI LAB CONFIRMED THE PRESENCE OF THE K ANTIGEN, IN MANUAL CAPTURE, ON RETENTION CAPTURE-R READY-SCREEN (3), LOT R683 USING CAPTURE-R READY INDICATOR RED CELL, LOT 221520 WITH ANTI-K, LOT 28150728-23 (1:128 DILUTION). RETENTION PRODUCT PERFORMED AS EXPECTED. THE PI LAB PERFORMED TESTING ON THE CUSTOMERS RETURNED SAMPLE ON THE ECHO USING RETENTION PRODUCT. THE CUSTOMERS SAMPLE RESULTED AS NEGATIVE ON ALL CELLS. AN IMMUCOR FIELD SERVICE ENGINEER PERFORMED THE UNEXPECTED REACTION CHECKLIST. ALL PARAMETERS POST INSPECTION WERE WITHIN SPECIFICATION. REPLACED PERI-PUMP TUBING DUE TO LOW DISPENSE VOLUME OF 9.6 ML (SPECIFICATION IS BETWEEN 9.9 AND 10.9 ML). POST INSPECTION, VOLUME AT 10.5 ML. QC WAS PERFORMED AND PASSED. TESTING WAS PERFORMED WITH KNOWN KELL POSITIVE SAMPLE. A POSITIVE RESULT WAS OBTAINED. UNEXPECTED REACTIVITY APPEARS TO BE SAMPLE-RELATED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A CUSTOMER REPORTED OBTAINING UNEXPECTED/INCONSISTENT ANTIBODY SCREENING RESULTS WHEN USING CAPTURE-R READY-SCREEN (3) ON A GALILEO ECHO INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13583 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R683

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR