BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMIRADX SARS-COV-2 AG TEST

    MDR report key: 13479698 · Received February 7, 2022

    Report

    Report Number
    MW5107267
    Event Type
    Malfunction
    Date Received
    February 7, 2022
    Date of Event
    February 3, 2022
    Report Date
    February 4, 2022
    Manufacturer
    LUMIRADX SAN DIEGO
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FOR REPORT MW5107267: PROVIDE PROCODE QKP.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FOR REPORT MW5107267: PROVIDE PROCODE QKP.

    Description of Event or Problem · 0

    FALSE POSITIVE TEST. TESTED DAY BEFORE USING A PCR TEST FROM VIRGINIA DEPT OF HEALTH DAY BEFORE AND AFTER. BOTH PCRS WERE NEGATIVE AND THE RAPID ANTIGEN TEST WAS POSITIVE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2406636 LUMIRADX SARS-COV-2 AG TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP LUMIRADX SAN DIEGO
    89875 LUMIRADX SARS-COV-2 AG TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP LUMIRADX SAN DIEGO

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male GINGER| PROBIOTICS| TUMERIC