BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAKAUTO ASSAY

    MDR report key: 4036601 · Received August 15, 2014

    Report

    Report Number
    2183608-2014-00008
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Date of Event
    October 8, 2013
    Report Date
    October 8, 2013
    Manufacturer
    IMMUCOR GTI DIAGNOSTICS, INC.
    Product Code
    MZI
    PMA / PMN Number
    BK960059
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT WAS RECEIVED (CMP-139), WHERE CUSTOMER IS CONCERNED BOUT INCREASE IN NUMBER OF BORDERLINE POSITIVE SAMPLES IN THE PAST TWO MONTHS, WITH PAKAUTO ASSAY LOT 3000951. CUSTOMER CLAIMED THEIR HISTORIC REACTIVITY RATE TO BE AROUND 18 PERCENT AND NOW IT HAS INCREASED TO AROUND 42 PERCENT. THE CUSTOMER WAS ALSO CONCERNED ABOUT THEIR TECHNIQUE FOR PREPARING ELUATES, AND FUNCTIONING OF THEIR LABORATORY CENTRIFUGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490629 PAKAUTO ASSAY PAKAUTO ASSAY MZI IMMUCOR GTI DIAGNOSTICS, INC. NA 3000951

    Patients

    Seq Age Sex Outcome Treatment
    1 NA