BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIA MEASLES IGM ELISA KIT

    MDR report key: 11584644 · Received March 29, 2021

    Report

    Report Number
    1318654-2021-00001
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    February 10, 2021
    Report Date
    March 25, 2021
    Manufacturer
    TRINITY BIOTECH USA
    Product Code
    PCL
    UDI-DI
    05391516743655
    PMA / PMN Number
    K140455
    Removal / Correction Number
    1318354-03/17/2021-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LABORATORY USER INFORMED MANUFACTURER THAT CAPTIA MEASLES IGM KIT WAS REPORTING INVALID ASSAYS ON TWO KITS FROM LOT 060 DUE TO POSITIVE CONTROL VALUES BEING ABOVE THE ASSIGNED ISR RANGE. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480904 CAPTIA MEASLES IGM ELISA KIT MEASLES IGM ELISA PCL TRINITY BIOTECH USA 2326060 060 05391516743655

    Patients

    Seq Age Sex Outcome Treatment
    1