BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKVUE AT-HOME OTC COVID-19 TEST

    MDR report key: 12573418 · Received October 4, 2021

    Report

    Report Number
    0002024674-2021-00058
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 28, 2021
    Report Date
    October 4, 2021
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QKP
    UDI-DI
    30014613339724
    PMA / PMN Number
    EUA210269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUBJECT: QV OTC, 3 FALSE POSITIVES, 3 NEGATIVE PCR TESTS--TSS ADVISED PATIENT TO FOLLOW UP WITH HCP INVESTIGATION CONCLUSION: TESTED 5X RETAINED DEVICES WITH NEGATIVE STANDARD. ALL DEVICES YIELDED VALID AND ACCURATE NEGATIVE RESULTS AT THE 10 MINUTE RESULT READ TIME. INVESTIGATION SUMMARY: IN RESPONSE TO YOUR COMPLAINT, WE TESTED RETAINED DEVICES FROM THE REPORTED LOT WITH NEGATIVE STANDARD. IN OUR QUALITY CONTROL LABORATORY, ALL THE RETAINED DEVICES TESTED YIELDED VALID AND ACCURATE NEGATIVE RESULTS AT THE TEN (10) MINUTE RESULT READ TIME. ALTHOUGH WE WERE UNABLE TO DUPLICATE YOUR COMPLAINT, THE INFORMATION YOU PROVIDED HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED. ROOT CAUSE: CND W/ RETAINS.

    Additional Manufacturer Narrative · 0

    SUBJECT: QV OTC, 3 FALSE POSITIVES, 3 NEGATIVE PCR TESTS. TSS ADVISED PATIENT TO FOLLOW UP WITH HCP. INVESTIGATION CONCLUSION: TESTED 5X RETAINED DEVICES WITH NEGATIVE STANDARD. ALL DEVICES YIELDED VALID AND ACCURATE NEGATIVE RESULTS AT THE 10 MINUTE RESULT READ TIME. INVESTIGATION SUMMARY: IN RESPONSE TO YOUR COMPLAINT, WE TESTED RETAINED DEVICES FROM THE REPORTED LOT WITH NEGATIVE STANDARD. IN OUR QUALITY CONTROL LABORATORY, ALL THE RETAINED DEVICES TESTED YIELDED VALID AND ACCURATE NEGATIVE RESULTS AT THE TEN (10) MINUTE RESULT READ TIME. ALTHOUGH WE WERE UNABLE TO DUPLICATE YOUR COMPLAINT, THE INFORMATION YOU PROVIDED HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED. ROOT CAUSE: COULD NO DETERMINE WITH RETAINS. FOLLOW-UP TO CHANGE PRODUCT CODE FROM QMN TO QKP (CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM).

    Additional Manufacturer Narrative · 0

    FOLLOW-UP TO CORRECT THE PRODUCT CODE TO QKP

    Description of Event or Problem · 0

    QV OTC, 3 FALSE POSITIVES, 3 NEGATIVE PCR TESTS--TSS ADVISED PATIENT TO FOLLOW UP WITH HCP.

    Description of Event or Problem · 0

    QV OTC, 3 FALSE POSITIVES, 3 NEGATIVE PCR TESTS. TSS ADVISED PATIENT TO FOLLOW UP WITH HCP.

    Description of Event or Problem · 0

    QV OTC, 3 FALSE POSITIVES, 3 NEGATIVE PCR TESTS. TSS ADVISED PATIENT TO FOLLOW UP WITH HCP

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471151 QUICKVUE AT-HOME OTC COVID-19 TEST QUICKVUE AT-HOME OTC COVID-19 TEST QKP QUIDEL CORPORATION 20402 30014613339724

    Patients

    Seq Age Sex Outcome Treatment
    1