BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCIRA CHECK-IT COVID-19 TEST

    MDR report key: 17612398 · Received August 24, 2023

    Report

    Report Number
    3016521-2023-00484
    Event Type
    Malfunction
    Date Received
    August 24, 2023
    Date of Event
    August 9, 2023
    Report Date
    August 22, 2023
    Manufacturer
    PFIZER, INC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS BASED ON THE AVAILABLE INFORMATION CAPTURED IN THE COMPLAINT DETAILS. THE ISSUE OF "FALSE POSITIVE" WAS REPORTED. NO HARM(S) WERE REPORTED. BASED ON A REVIEW OF THE RISK MANAGEMENT FILE FOR THE LUCIRA COVID-19 & FLU TEST KIT, FALSE POSITIVE TEST RESULTS ARE A KNOWN POSSIBLE FAILURE; REFER TO FMEA009 AND FMEA011. A SUPPLEMENTAL REPORT WILL BE FILED IF ANY FURTHER INVESTIGATION AND/OR ADDITIONAL INFORMATION IS OBTAINED. THIS DEVICE IS MARKETED UNDER EUA 220490. A DHR REVIEW CANNOT BE COMPLETED AS LOT INFORMATION WAS NOT PROVIDED. BASED ON THE INFORMATION ABOVE, NO FURTHER INVESTIGATION IS REQUIRED. A MOST PROBABLE ROOT CAUSE CANNOT BE DETERMINED WITHOUT RETURNED PRODUCT. POTENTIAL ROOT CAUSES INCLUDE BUT ARE NOT LIMITED TO: LOW VIRAL LOAD, ENVIRONMENT, IMPROPER COLLECTION/HANDLING, DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    CUSTOMER CONTACTED US ON 08/09/2023 TO REPORT A FALSE POSITIVE RESULT. CUSTOMER TOOK A LUCIRA COVID -19 AND MULTIPLE ANTIGEN TESTS AND ALL OF THEM GAVE A NEGATIVE RESULT. CUSTOMER MENTIONED THAT SHE WAS GOING TO TAKE A PCR LAB TEST. HOWEVER, SHE HAS NOT REPLIED BACK TO OUR FOLLOW-UP EMAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038865 LUCIRA CHECK-IT COVID-19 TEST COVID-19-TEST KIT QJR PFIZER, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other