BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKVUE AT-HOME OTC COVID-19 TEST

    MDR report key: 12558716 · Received September 30, 2021

    Report

    Report Number
    0002024674-2021-00051
    Event Type
    Malfunction
    Date Received
    September 30, 2021
    Date of Event
    September 10, 2021
    Report Date
    September 30, 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: CUSTOMER SPILLED QUICKVUE OTC REAGENT ON FINGER & IS CONCERNED ABOUT HOW FINGER LOOKS -- TSS ADVISED CUSTOMER PER SDS TO WASH SKIN WITH PLENTY OF WATER & CONTACT POISON CONTROL/DOCTOR/PHYSICIAN. 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.

    Additional Manufacturer Narrative · 0

    SUBJECT: CUSTOMER SPILLED QUICKVUE OTC REAGENT ON FINGER & IS CONCERNED ABOUT HOW FINGER LOOKS -- TSS ADVISED CUSTOMER PER SDS TO WASH SKIN WITH PLENTY OF WATER & CONTACT POISON CONTROL/DOCTOR/PHYSICIAN 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.

    Description of Event or Problem · 0

    CUSTOMER SPILLED QUICKVUE OTC REAGENT ON FINGER & IS CONCERNED ABOUT HOW FINGER LOOKS -- TSS ADVISED CUSTOMER PER SDS TO WASH SKIN WITH PLENTY OF WATER & CONTACT POISON CONTROL/DOCTOR/PHYSICIAN.

    Description of Event or Problem · 0

    CUSTOMER SPILLED QUICKVUE OTC REAGENT ON FINGER & IS CONCERNED ABOUT HOW FINGER LOOKS -- TSS ADVISED CUSTOMER PER SDS TO WASH SKIN WITH PLENTY OF WATER & CONTACT POISON CONTROL/DOCTOR/PHYSICIAN.

    Description of Event or Problem · 0

    CUSTOMER SPILLED QUICKVUE OTC REAGENT ON FINGER & IS CONCERNED ABOUT HOW FINGER LOOKS -- TSS ADVISED CUSTOMER PER SDS TO WASH SKIN WITH PLENTY OF WATER & CONTACT POISON CONTROL/DOCTOR/PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454652 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