BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCIRA CHECK-IT COVID-19 TEST

    MDR report key: 18242491 · Received November 30, 2023

    Report

    Report Number
    3016521623-2023-00502
    Event Type
    Malfunction
    Date Received
    November 30, 2023
    Date of Event
    November 16, 2023
    Report Date
    November 29, 2023
    Manufacturer
    PFIZER, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 AFTER TEST" WERE REPORTED. NOTE THAT THE AFFECTED PRODUCT FOR "INVALID AFTER TEST" 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(S) WERE REPORTED. REFER TO (B)(4) FOR THE COMPLETE INVESTIGATION. BASED ON THE INFORMATION IN THE ATTACHED INVESTIGATION, NO FURTHER INVESTIGATION IS REQUIRED. MONITORING OF "FALSE POSITIVE", "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. 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). A MOST PROBABLE ROOT CAUSE FOR THE ISSUE OF "INVALID AFTER TEST" CANNOT BE DETERMINED WITHOUT RETURNED/EVALUATED PRODUCT. EXPECTED DEVICE FUNCTIONALITY CANNOT BE GUARANTEED AFTER THE EXPIRATION DATE.

    Description of Event or Problem · 0

    "CUSTOMER CONTACTED ON (B)(3) 2023 TO REPORT A FALSE POSITIVE. EVIDENCE PROVIDED. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N? YES. MAY I HAVE YOUR LOT AND TEST KIT #?. LOT #: K08A111505233M2. TEST KIT #: 3A9T1E1H. 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? YES. 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? 1 LUCIRA AND 2 ANTIGEN. HOW MANY TOTAL TESTS WERE RUN BEFORE GETTING THIS FALSE POSITIVE? 3. 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 ON 16/11/2023 TO REPORT 4 INVALID TESTS AFTER 30 MINUTES. EVIDENCE PROVIDED. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N? YES. MAY I HAVE YOUR LOT AND TEST KIT #? LOT #: K08A112209224M7, K08A111505233M2. TEST KIT #: 4A6M2B1R, 4A6M8M4D, 4A6M8M4C, 4M6M8M4B. IS YOUR KIT COVID FLU OR COVID 19? COVID 19. 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".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398954 LUCIRA CHECK-IT COVID-19 TEST COVID 19 TEST KIT QJR PFIZER, INC. K08A111505233M2

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other