BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCIRA CHECK-IT COVID-19 TEST

    MDR report key: 18877522 · Received March 11, 2024

    Report

    Report Number
    3016521623-2024-00510
    Event Type
    Malfunction
    Date Received
    March 11, 2024
    Date of Event
    February 26, 2024
    Report Date
    March 11, 2024
    Manufacturer
    PFIZER, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS BASED ON THE AVAILABLE INFORMATION CAPTURED IN THE COMPLAINT DETAILS. THE ISSUES OF "FALSE POSITIVE" AND "INVALID/INVALID AFTER TEST" WERE REPORTED. NOTE THAT THE AFFECTED PRODUCT FOR "FALSE POSITIVE" WAS DETERMINED TO BE EXPIRED AT THE TIME OF USE AND THEREFORE WILL BE INVESTIGATED AS "USE ERROR". PRODUCT IS USED FOR DIAGNOSTIC PURPOSES. NO HARM WAS 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 POSITIVE", "INVALID/INVALID AFTER TEST", AND "USE ERROR" WILL CONTINUE AND THERE ARE NO ADDITIONAL RECOMMENDED ACTIONS AT THIS POINT. A MOST PROBABLE ROOT CAUSE FOR THE ISSUE OF "FALSE POSITIVE" CANNOT BE DETERMINED WITHOUT RETURNED/EVALUATED PRODUCT. EXPECTED DEVICE FUNCTIONALITY CANNOT BE GUARANTEED AFTER THE EXPIRATION DATE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A FALSE POSITIVE. THE CUSTOMER RAN THE TEST ON MONDAY (B)(4) 2024. EVIDENCES NOT PROVIDED. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N YES. MAY I HAVE YOUR LOT AND TEST KIT #? LOT #: K08A112203224M3 TEST KIT #: 4A6F2H8C. LOCATION OF TESTING? INDOOR/OUTDOOR INDOOR. WAS THE TEST COMPLETED ON A FLAT SURFACE? Y/N YES. WAS THE SWAB ROTATED 5 TIMES IN EACH NOSTRIL? Y/N YES. WERE YOU 6 FEET FROM ANOTHER PERSON WHEN TAKING THE TEST? NO. WERE YOU EXPOSED TO COVID WITH IN THE PREVIOUS 24 HOURS OF TESTING? NO. WAS THE VIAL LIQUID PURPLE IN COLOR? Y/N YES. WAS THE TEST MOVED WHILE IT WAS RUNNING? Y/N NO. HOW SOON AFTER THE INITIAL POSITIVE TEST WAS A RETEST(S) COMPLETED? 30MIN. WHAT TEST DID YOU USE TO CONFIRM THE FALSE POSITIVE? LUCIRA, VINEX, PCR. HOW MANY TOTAL TESTS WERE RUN BEFORE GETTING THIS FALSE POSITIVE? 0. DID THE PERSON TESTED, CONTACT A HEALTHCARE PROVIDER? Y/N YES. IF YES, HOW IS THE PERSON TESTED DOING? IS THE PERSON TESTED UNDERGOING ANY TREATMENT? NO. IS YOUR KIT COVID/ FLU OR COVID 19? COVID 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2456513 LUCIRA CHECK-IT COVID-19 TEST COVID 19 TEST KIT QJR PFIZER, INC. K08A112203224M3

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other