BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSW100 WASHING SYSTEM

    MDR report key: 5057819 · Received September 4, 2015

    Report

    Report Number
    1034569-2015-00130
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    July 28, 2015
    Report Date
    September 4, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    JQW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE UNABLE TO RULE OUT THE ISSUE BEING RELATED TO THE TECHNIQUE AND OR HANDLING OF THE TESTING ON THE MANUAL CAPTURE BY THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE (COMPATIBLE) CROSSMATCH RESULTS FOR A PATIENT SAMPLE CONTAINING ANTI-JKB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588460 CSW100 WASHING SYSTEM MICROPLATE WASHER JQW IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR