BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIA NMT SYPHILIS IGM KIT

    MDR report key: 11841154 · Received May 18, 2021

    Report

    Report Number
    1318654-2021-00002
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 15, 2021
    Report Date
    May 14, 2021
    Manufacturer
    TRINITY BIOTECH USA
    Product Code
    LIP
    UDI-DI
    05391516745048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS MANUFACTURED FOR EXPORT ONLY AND NOT SOLD IN THE US. THE EVENT OCCURRED IN (B)(6) AND WAS REPORTED AS A FIELD SAFETY CORRECTIVE ACTION TO HPRA.

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT WAS RECEIVED STATING THAT THE LABELS FOR THE POSITIVE AND NEGATIVE CONTROLS WERE ON THE WRONG BOTTLES. THE CUSTOMER PROVIDED PHOTOGRAPHS OF THE CONTROLS WHICH CONFIRMED THE KIT THEY HAD RECEIVED DID HAVE THE CONTROLS LABELLED INCORRECTLY. THE CUSTOMER FOUND THE ERROR PRIOR TO USING THE KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742463 CAPTIA NMT SYPHILIS IGM KIT CAPTIA NMT SYPHILIS IGM KIT LIP TRINITY BIOTECH USA 2329360 125 05391516745048

    Patients

    Seq Age Sex Outcome Treatment
    1 Other