BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAR DX TRINITY BIOTECH MARDX EU LYME + VLSE IGG WESTERN BLOT,

    MDR report key: 21892122 · Received April 23, 2025

    Report

    Report Number
    MW5169461
    Event Type
    Injury
    Date Received
    April 23, 2025
    Date of Event
    May 6, 2020
    Report Date
    April 20, 2025
    Manufacturer
    MARDX DIAGNOSTICS INC./ TRINITY BIOTECH USA
    Product Code
    LSR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CRITICAL MEDICAL INCIDENTS OCCURRED INCLUDING INJURIES DUE TO FAULTY MEDICAL DEVICES MAR DX TRINITY BIOTECH WB CLASS II TGA, TWO-TIER LYME DISEASE SEROLOGY NATA ACCREDITED AND RCPA VALIDATED TESTING APPROACH FAILED: PATIENT COMPLAINT WITH SCIENTIFIC EVIDENCE. PATIENT PERFORMED PROCESS VALIDATION ON A REAL BLOOD SPECIMEN OF FEW NATA ACCREDITED HIGH VOLUME LABORATORY FACILITIES WHICH PRODUCED FALSE NEGATIVE DISCORDANT RESULTS, LED TO LATE-STAGE NEUROLOGICAL LYME DISEASE AND 5 YEARS DELAY OF IV ANTIBIOTIC TREATMENT. FALSE NEGATIVE DISCORDANT RESULT GENERATED. LATE-STAGE NEUROLOGICAL LYME DISEASE AS AN OUTCOME FROM A FAULTY MEDICAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560648 MAR DX TRINITY BIOTECH MARDX EU LYME + VLSE IGG WESTERN BLOT, REAGENT, BORRELIA SEROLOGICAL REAGENT LSR MARDX DIAGNOSTICS INC./ TRINITY BIOTECH USA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Hospitalization| S| O| R| L