BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCIRA CHECK-IT COVID-19 TEST

    MDR report key: 19872227 · Received July 31, 2024

    Report

    Report Number
    3016521623-2024-00530
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    July 20, 2024
    Report Date
    July 31, 2024
    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 NEGATIVE" WAS REPORTED. PRODUCT IS USED FOR DIAGNOSTIC PURPOSES. NO HARM(S) WERE REPORTED. REFER TO (B)(4). PDF FOR THE COMPLETE INVESTIGATION. BASED ON THE INFORMATION IN THE ATTACHED INVESTIGATION, NO FURTHER INVESTIGATION IS REQUIRED. MONITORING OF "FALSE NEGATIVE" WILL CONTINUE AND THERE ARE NO ADDITIONAL RECOMMENDED ACTIONS AT THIS POINT. A MOST PROBABLE ROOT CAUSE CANNOT BE DETERMINED WITHOUT RETURNED PRODUCT. POTENTIAL ROOT CAUSES INCLUDE BUT ARE NOT LIMITED TO: NO AMPLIFICATION/REDUCED AMPLIFICATION EFFICIENCY (DESIGN DEFECT). ASSAY CONTAMINATION/DEGRADATION (PROCESS FAILURE) IMPROPER STORAGE/HANDLING (USE ERROR).

    Description of Event or Problem · 0

    THE CUSTOMER PROVIDED A REVIEW ON AMAZON ON 07/20/2024, AND IT WAS PUBLICLY VISIBLE UNTIL 07/23/2024. THE CUSTOMER WAS REPORTING A FALSE NEGATIVE RESULT - AFTER TEST RUN. EVIDENCE PROVIDED WAS THE TEST KIT PHOTO. NO OTHER DETAILS, INCLUDING LOT NUMBER, WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984318 LUCIRA CHECK-IT COVID-19 TEST COVID 19 TEST KIT QJR PFIZER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other