BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPTIA¿ SYPHILIS (T. PALLIDUM) IGG

    MDR report key: 7626067 · Received June 21, 2018

    Report

    Report Number
    3022521-2018-00003
    Event Type
    Injury
    Date Received
    June 21, 2018
    Date of Event
    April 16, 2018
    Report Date
    June 20, 2018
    Manufacturer
    TRINITY BIOTECH USA
    Product Code
    LIP
    UDI-DI
    05391516744829
    PMA / PMN Number
    K001525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BIO-RAD TECHNICAL SUPPORT WAS CONTACTED ON (B)(6) 2018 BY A BIO-RAD ACCOUNT MANAGER ON BEHALF OF THE CUSTOMER AT CERRITOS REFERENCE LAB. THE CUSTOMER HAD A QUESTION AS TO HOW THEY SHOULD BE REPORTING RESULTS FOR CAPTIA¿ (B)(6). THE CUSTOMER HAD SWITCHED FROM RPR TESTING TO CAPTIA¿ (B)(6) IGG TESTING DURING THE THIRD WEEK OF (B)(6) 2018, AND THE CUSTOMER WAS REPORTING THE CAPTIA¿ SYPHILIS (T. PALLIDUM) IGG RESULTS OUT AS RPR RESULTS. BIO-RAD TECHNICAL SUPPORT INFORMED THE CUSTOMER THAT THEY HAVE BEEN REPORTING OUT THE RESULTS INCORRECTLY, AND PROVIDED THE INFORMATION AS TO HOW THE RESULTS SHOULD BE REPORTED. AS PART OF THE INCIDENT INVESTIGATION BIO-RAD TECHNICAL SUPPORT DISCOVERED THAT THE CUSTOMER WAS RUNNING CAPTIA¿ (B)(6) IGG FOR TESTS THAT WERE ORDERED AS RPR, AND THAT THE TESTS WERE REPORTED AS RPR. THE CUSTOMER REPORTED THAT THEY HAVE SENT A LETTER OUT INFORMING ALL OF THEIR CLINICS OF THE SITUATION, AND THAT THE CUSTOMER WILL TAKE CORRECTIVE ACTION TO RESOLVE THE INCIDENT. THIS INCIDENT IS USER ERROR AS THE CUSTOMER DID NOT PERFORM THE TEST THAT WAS ORDERED BY THE PHYSICIAN, AND THE CUSTOMER REPORTED OUT RESULTS INCORRECTLY. BECAUSE RESULTS WERE REPORTED OUT INCORRECTLY THERE IS POTENTIAL FOR HARM TO THE PATIENT DUE TO DELAYED TREATMENT OR MISDIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469332 CAPTIA¿ SYPHILIS (T. PALLIDUM) IGG EIA LIP TRINITY BIOTECH USA 05391516744829

    Patients

    Seq Age Sex Outcome Treatment
    1 Other