BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 3102512 · Received May 9, 2013

    Report

    Report Number
    1034569-2013-00074
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL REVIEW OF RESULTS FOR THE UNEXPECTED NEGATIVE REACTIVITY SHOWED THAT NEGATIVE REACTIONS APPEARED AS REPORTED BY THE INSTRUMENT. THE CUSTOMER REPLACED THE STIRRING RACK ON THE NEO. INCONSISTENT RESULTS WERE OBTAINED WITH REPEAT TESTING ON THE ECHO AND NEO INSTRUMENTS. WE WERE UNABLE TO RULE OUT A SAMPLE-RELATED ISSUE. THE IMMUCOR PRODUCT INVESTIGATIONS LAB CONFIRMED THE PRESENCE OF THE JKA ANTIGEN ON RETENTION PRODUCT. THE RETENTION PRODUCT PERFORMED AS EXPECTED. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE REACTIVITY WITH CAPTURE-R READY-SCREEN (3), LOT R290, ON THE NEO INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204194 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R291

    Patients

    Seq Age Sex Outcome Treatment
    1 32