BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPLEX 2200

    MDR report key: 13093186 · Received December 27, 2021

    Report

    Report Number
    MW5106283
    Event Type
    Malfunction
    Date Received
    December 27, 2021
    Date of Event
    December 7, 2021
    Report Date
    December 23, 2021
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Product Code
    LIP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    COVID VACCINE POSSIBLY CAUSED FALSE POSITIVE RESULT WITH SYPHILIS LAB TEST. ORIGINAL LAB TEST THAT WAS CONDUCTED ON (B)(6) WAS REACTIVE MINIMAL. I HAD ANOTHER LAB RPR, RFX QN RPR/CONFIRM TP-012005 AND THE RESULT WAS NEGATIVE. I RECEIVED MODERNA COVID VACCINE ON (B)(6). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986119 BIOPLEX 2200 ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM LIP BIO-RAD LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other