BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPLEX HIV AB-AG

    MDR report key: 11163412 · Received January 12, 2021

    Report

    Report Number
    MW5098797
    Event Type
    Injury
    Date Received
    January 12, 2021
    Date of Event
    August 21, 2020
    Report Date
    January 10, 2021
    Manufacturer
    BIO-RAD LABORATORIES INC.
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SEVERE ANXIETY AND CONFUSION; HI I'M A PATIENT FROM (B)(6), I HAD A ROUTINE BLOOD WORK THAT INCLUDED (B)(6) SCREENING USING BIOPLEX 2200. MY SCREENING CAME BACK (B)(6) FOR (B)(6) HOWEVER WAS (B)(6) BY FURTHER TESTING IN OTHER PLATFORMS AND I ALSO DIDN'T HAVE ANY CLINICAL REASONS FOR (B)(6) WHICH CONFUSED ALL CLINICIANS INVOLVED IN MY CASE. DURING THE PROCESS I RAN INTO SOMEONE ELSE WHO ALSO HAD THE SAME EXACT ISSUE WITH THIS PLATFORM AROUND THE SAME TIME IN THE US AS WELL SO THIS SEEMS TO BE GLITCHES THAT IS HAPPENING WITH BIOPLEX BIORAD. I CONTACTED THE COMPANY TO SEE IF THEY KNOW ANYTHING ABOUT THIS MAYBE COVID IS CAUSING CROSS REACTION? THEY DIDN'T RESPOND TO ME BUT I REALLY BELIEVE THIS NEEDS TO BE INVESTIGATED SINCE IT HAPPENED TO TWO LOW RISK INDIVIDUALS FROM THE US WITH FURTHER (B)(6) TESTING. BEST . FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54270 BIOPLEX HIV AB-AG TEST, HIV DETECTION MZF BIO-RAD LABORATORIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1