BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKVUE AT-HOME OTC COVID-19 TEST

    MDR report key: 12558734 · Received September 30, 2021

    Report

    Report Number
    0002024674-2021-00053
    Event Type
    Malfunction
    Date Received
    September 30, 2021
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QKP
    PMA / PMN Number
    EUA210269
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUBJECT: QV OTC, CUSTOMER SWABBED NOSE AND IT PRODUCED A SMALL AMOUNT OF BLOOD, WILL THIS AFFECT THE RESULTS?--TSS ADVISED THE CUSTOMER A MINIMAL AMOUNT OF BLOOD SHOULD NOT INTERFERE WITH THE RESULTS, RETEST BY SWABBING OTHER NOSTRIL INVESTIGATION CONCLUSION: NA. INVESTIGATION SUMMARY: TS REACHED OUT FOR A WELL-CHECK. VMS WERE LEFT AND CASE HAS BEEN UPDATED WITH THE FOLLOW UP ATTEMPT ROOT CAUSE: CUSTOMER PROCEDURAL ERROR.

    Additional Manufacturer Narrative · 0

    SUBJECT: QV OTC, CUSTOMER SWABBED NOSE AND IT PRODUCED A SMALL AMOUNT OF BLOOD, WILL THIS AFFECT THE RESULTS?--TSS ADVISED THE CUSTOMER A MINIMAL AMOUNT OF BLOOD SHOULD NOT INTERFERE WITH THE RESULTS, RETEST BY SWABBING OTHER NOSTRIL INVESTIGATION CONCLUSION: NA. INVESTIGATION SUMMARY: TS REACHED OUT FOR A WELL-CHECK. VMS WERE LEFT AND CASE HAS BEEN UPDATED WITH THE FOLLOW UP ATTEMPT. ROOT CAUSE: CUSTOMER PROCEDURAL ERROR. 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, CUSTOMER SWABBED NOSE AND IT PRODUCED A SMALL AMOUNT OF BLOOD, WILL THIS AFFECT THE RESULTS?--TSS ADVISED THE CUSTOMER A MINIMAL AMOUNT OF BLOOD SHOULD NOT INTERFERE WITH THE RESULTS, RETEST BY SWABBING OTHER NOSTRIL.

    Description of Event or Problem · 0

    QV OTC, CUSTOMER SWABBED NOSE AND IT PRODUCED A SMALL AMOUNT OF BLOOD, WILL THIS AFFECT THE RESULTS?--TSS ADVISED THE CUSTOMER A MINIMAL AMOUNT OF BLOOD SHOULD NOT INTERFERE WITH THE RESULTS, RETEST BY SWABBING OTHER NOSTRIL.

    Description of Event or Problem · 0

    QV OTC, CUSTOMER SWABBED NOSE AND IT PRODUCED A SMALL AMOUNT OF BLOOD, WILL THIS AFFECT THE RESULTS?--TSS ADVISED THE CUSTOMER A MINIMAL AMOUNT OF BLOOD SHOULD NOT INTERFERE WITH THE RESULTS, RETEST BY SWABBING OTHER NOSTRIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455083 QUICKVUE AT-HOME OTC COVID-19 TEST QUICKVUE AT-HOME OTC COVID-19 TEST QKP QUIDEL CORPORATION 20402

    Patients

    Seq Age Sex Outcome Treatment
    1