BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKVUE SARS ANTIGEN TEST

    MDR report key: 14366374 · Received May 11, 2022

    Report

    Report Number
    0002024674-2022-03774
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Date of Event
    September 9, 2021
    Report Date
    May 11, 2022
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QKP
    UDI-DI
    30014613339373
    PMA / PMN Number
    EUA203086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: TESTED 5X RETAINED DEVICES WITH NEGATIVE STANDARD. ALL DEVICES YIELDED VALID AND ACCURATE NEGATIVE RESULTS AT THE 10 MINUTE RESULT READ TIME. TESTED 2X RETURNED DEVICES, ONE FROM EACH REPORTED POUCH LOTS 201689 AND 201765. ALL DEVICES YIELDED VALID AND ACCURATE NEGATIVE RESULTS AT THE 10 MINUTE RESULT READ TIME. ROOT CAUSE: COULD NOT DUPLICATE RETAIN & RETURN. SOURCE: EMAIL.

    Description of Event or Problem · 0

    REPORTED 1 FALSE POSITIVE RESULT FOR 1 ASYMPTOMATIC PATIENT. THE CUSTOMER COMMUNICATED THE RESULT WAS CONFIRMED NEGATIVE BY MOLECULAR (PCR TESTING). THE CUSTOMER COULDN'T NARROW DOWN THE SPECIFIC LOT, BUT GAVE MULTIPLE POSSIBLE LOTS USED IN THE TIMEFRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113716 QUICKVUE SARS ANTIGEN TEST QUICKVUE SARS ANTIGEN TEST QKP QUIDEL CORPORATION 201765, 201689, 148680 30014613339373

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown