BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAKAUTO ASSAY

    MDR report key: 4036656 · Received August 15, 2014

    Report

    Report Number
    2183608-2014-00009
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    IMMOCUR GTI DIAGNOSTICS, INC.
    Product Code
    MZI
    PMA / PMN Number
    BK960059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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-76), WHERE CUSTOMER WAS SEEING VERY LOW O.D. VALUES (-0.01 - 0.014) WITH THEIR IN-HOUSE NEGATIVE ELUATE CONTROL (NCP), WHEN USING PAKAUTO ASSAY LOT 300655. THIS LEAD TO LOW ASSAY CUT-OFF VALUE (0.020 - 0.028), WHICH RESULTED IN ALMOST EVERY PATIENT ON THE PLAT HAVING A POSITIVE RESULT WITH ALMOST ALL GLYCOPROTEINS (GPS). CUSTOMER INFORMED THA THEY OBTAINED LOW OD VALUES WITH BOTH THEIR IN-HOUSE NCP AND KIT NCP, AND OCCURRENCE OF THE LOW NCP OD VALUES SEEMED SPORADIC. CUSTOMER'S QC DATA TRACKING OVER THE YEARS SHOW THAT THE NCP OD VALUE TYPICALLY RUNS BETWEEN 0.030-0.068.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490487 PAKAUTO ASSAY PAKAUTO ASSAY MZI IMMOCUR GTI DIAGNOSTICS, INC. NA 300655

    Patients

    Seq Age Sex Outcome Treatment
    1 NA