BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR CELLS

    MDR report key: 3533712 · Received December 23, 2013

    Report

    Report Number
    1034569-2013-00218
    Event Type
    Malfunction
    Date Received
    December 23, 2013
    Date of Event
    November 29, 2013
    Report Date
    December 23, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS ASKED TO REPEAT TESTING ON ECHO M00966 USING LOT 221087. NEGATIVE RESULTS WERE OBTAINED. THE CUSTOMER ALSO PERFORMED TESTING ON M00967 USING LOT 221086. POSITIVE RESULTS WERE OBTAINED. NO PRODUCT OR PATIENT SAMPLE HAS BEEN SUBMITTED FOR INVESTIGATION. THE CUSTOMERS VIAL OF INDICATOR CELLS MAY HAVE BECOME COMPROMISED. REPLACEMENT PRODUCT WAS PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE REACTIVITY ON GALILEO ECHO M00967.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673260 CAPTURE-R READY INDICATOR CELLS ANTI-IGG COATED RED BLOOD CELLS KSZ IMMUCOR, INC. 221087

    Patients

    Seq Age Sex Outcome Treatment
    1