BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAKAUTO

    MDR report key: 8002478 · Received October 24, 2018

    Report

    Report Number
    2183608-2018-00031
    Event Type
    Malfunction
    Date Received
    October 24, 2018
    Date of Event
    October 2, 2018
    Report Date
    September 20, 2018
    Manufacturer
    IMMUCOR GTI DIAGNOSTICS, INC.
    Product Code
    MYP
    UDI-DI
    10888234500247
    PMA / PMN Number
    BK960059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    (B)(6) 2018. THE CUSTOMER RETURNED KIT FROM LOT 3006837 (PA) WAS TESTED IN PARALLEL WITH AN IMMUCOR-WKS RETENTION KIT FROM LOT 3006837 (PA) ON (B)(6) 2018. THE CUSTOMER RETURNED KIT AND THE RETENTION KIT FROM LOT 3006837 (PA) GAVE NEGATIVE CONTROL OD AVERAGE VALUES IN THE IIB/IIIA ROWS THAT DID NOT MEET IFU VALIDITY CRITERIA. THE NEGATIVE SERUM CONTROL IS RUN IN DUPLICATE WITH EACH TEST RUN. THE NEGATIVE SERUM CONTROL SHOULD GIVE AN AVERAGE OD VALUE OF < OR EQUAL TO 0.160 OD IN THE IIB/IIIA ROWS. THE CUSTOMER COMPLAINT ((B)(4)) WAS REPRODUCED. THE CUSTOMER WAS PERFORMING VALIDATION AND STUDY TESTING USING THE KIT. CORRECTIVE ACTION IS BEING TAKEN THROUGH FA-WKS-18-008, TO NOTIFY CUSTOMERS OF THE AFFECTED PAKAUTO LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842471 PAKAUTO PAKAUTO MYP IMMUCOR GTI DIAGNOSTICS, INC. 3006837 10888234500247

    Patients

    Seq Age Sex Outcome Treatment
    1