BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPEEDY SWAB TEST FOR COVID-19, FLU A AND FLU

    MDR report key: 22054261 · Received May 20, 2025

    Report

    Report Number
    MW5170620
    Event Type
    Other
    Date Received
    May 20, 2025
    Report Date
    May 15, 2025
    Manufacturer
    WATMIND USA
    Product Code
    QKP
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AN AT HOME COMBINED COVID, FLU A AND FLU B TEST WAS MISINTERPRETED AS POSITIVE BY AN RN IN A GROUP HOME DUE TO CONFUSING LABELS. THE RESULTS SECTION INCLUDES LINES LABELED C, A, B, AND S. THERE IS NOT A SEPARATE CONTROL SECTION. THE "C" IS FOR CONTROL, BUT THE NURSE INTERPRETED THE C AS STANDING FOR COVID. THE S IS FOR SARS COV-2 BUT LISTS THE RESULT AS "COVID-19 POSITIVE." INTERCHANGING THE NAMES FOR COVID IS CONFUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2321026 SPEEDY SWAB TEST FOR COVID-19, FLU A AND FLU CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP WATMIND USA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown