BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCIRA CHECK-IT COVID-19 TEST

    MDR report key: 18240687 · Received November 30, 2023

    Report

    Report Number
    3016521623-2023-00499
    Event Type
    Malfunction
    Date Received
    November 30, 2023
    Date of Event
    November 15, 2023
    Report Date
    November 22, 2023
    Manufacturer
    PFIZER, INC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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", "INVALID AT START", AND "INVALID/INVALID AFTER TEST" WERE REPORTED. PRODUCT IS USED FOR DIAGNOSTIC PURPOSES. NO HARMS WERE REPORTED. REFER TO (B)(4)_INVESTIGATION_22NOV2023.PDF FOR THE COMPLETE INVESTIGATION. BASED ON THE INFORMATION IN THE ATTACHED INVESTIGATION, NO FURTHER INVESTIGATION IS REQUIRED. MONITORING OF "FALSE POSITIVE" 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 EVALUATION OF RETURNED PRODUCT. POTENTIAL ROOT CAUSES INCLUDE BUT ARE NOT LIMITED TO: - ASSAY FALSE AMPLIFICATION (DESIGN DEFECT). - AIR BUBBLES IN REACTION CHAMBER (DESIGN DEFECT). - ASSAY CONTAMINATION/DEGRADATION (PROCESS FAILURE). - IMPROPER STORAGE/HANDLING (USE ERROR). REFER TO SCAR-2021-029 FOR "INVALID AT START". REFER TO CAPA-2022-015 FOR "INVALID/INVALID AFTER TEST".

    Description of Event or Problem · 0

    "CUSTOMER CONTACTED US ON (B)(6) 2023 TO REPORT A FALSE POSITIVE RESULT. EVIDENCE PROVIDED. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N YES. MAY I HAVE YOUR LOT AND TEST KIT #? LOT #: K08A111505233M2. TEST KIT #: 3A9T0U9R. 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? ANOTHER LUCIRA AND AN APTITUDE METRIX AND A RAPID ANTIGEN TEST HOW MANY TOTAL TESTS WERE RUN BEFORE GETTING THIS FALSE POSITIVE? 2[?]. DID THE PERSON TESTED, CONTACT A HEALTHCARE PROVIDER? Y/N NO. IF YES, HOW IS THE PERSON TESTED DOING? IS THE PERSON TESTED UNDERGOING ANY TREATMENT? - IS YOUR KIT COVID/ FLU OR COVID 19? COVID 19". "CUSTOMER CONTACTED US ON 11/15/2023 TO REPORT AN INVALID RESULT. ALL THE LIGHTS FLASHING AFTER BATTERIES INSERTED. EVIDENCE PROVIDED. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N YES. MAY I HAVE YOUR LOT AND TEST KIT #? LOT #: K08A111505233M2. TEST KIT #: 3A9T0V6L. IS YOUR KIT COVID FLU OR COVID 19? COVID 19. LOCATION OF TESTING? INDOOR/OUTDOOR INDOOR. DID YOU USE THE BATTERIES PROVIDED? YES. WERE THE BATTERIES INSERTED MORE THAN 5 MINUTES BEFORE THE TEST WAS RUN? NO". "CUSTOMER CONTACTED US ON 11/15/2023 TO REPORT A INVALID RESULT AFTER 30 MIN. EVIDENCE PROVIDED. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N YES. MAY I HAVE YOUR LOT AND TEST KIT #? LOT #: K10A013003234M1. TEST KIT #: 4A8F9E1L. IS YOUR KIT COVID FLU OR COVID 19? COVID FLU [?]. IS THERE ANY LIQUID LEFT IN THE VIAL? YES [?]. WAS THE READY LIGHT BLINKING WHEN YOU STIRRED THE SWAB? NO. WAS THE SWAB ROTATED 5 TIMES IN EACH NOSTRIL? Y/N YES. WAS THE SWAB STIRRED IN THE VIAL FOR AT LEAST 15 TIMES? YES. WAS THE VIAL LIQUID PURPLE IN COLOR? YES[?]. PLEASE PROVIDE THE STATUS OF EACH LED STATUS? (ONLY FOR COVID FLU KITS) COVID LED STATUS: POSITIVE::FLASHING. FLU A LED STATUS: POSITIVE::FLASHING. FLU B LED STATUS: POSITIVE::FLASHING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2071035 LUCIRA CHECK-IT COVID-19 TEST COVID-19-TEST KIT QJR PFIZER, INC K08A111505233M2

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other