BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCIRA CHECK-IT COVID-19 TEST

    MDR report key: 19144444 · Received April 19, 2024

    Report

    Report Number
    3016521623-2024-00520
    Event Type
    Malfunction
    Date Received
    April 19, 2024
    Date of Event
    April 11, 2024
    Report Date
    April 19, 2024
    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/INVALID AFTER TEST" WERE REPORTED. NOTE THAT THE AFFECTED PRODUCT FOR "INVALID/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) INVESTIGATION 19APR2024. 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 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/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 04/12/2024 TO REPORT A FALSE POSITIVE. EVIDENCE PROVIDED. TEST RAN ON 04/11/2024 BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N, YES. MAY I HAVE YOUR LOT AND TEST KIT #? LOT #: K10A112012233M3, TEST KIT #: 3A4C9E4R. 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? 1-4 HOURS. WHAT TEST DID YOU USE TO CONFIRM THE FALSE POSITIVE? FLU TEST NO BRAND CONFIRMED. HOW MANY TOTAL TESTS WERE RUN BEFORE GETTING THIS FALSE POSITIVE? 1. 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 FLU. PLEASE PROVIDE THE STATUS OF EACH LED STATUS? (ONLY FOR COVID/ FLU KITS): COVID LED STATUS: NEGATIVE: ON. FLU A LED STATUS: NEGATIVE: ON. FLU B LED STATUS: POSITIVE: ON". CUSTOMER CONTACTED ON 04/12/2024 TO REPORT AN INVALID TEST AFTER TEST RUN. EVIDENCE PROVIDED. TEST RAN ON (B)(6) 2024. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N, YES. MAY I HAVE YOUR LOT AND TEST KIT # LOT #: K10A011207233M6, TEST KIT #: 4A8T8K2T. IS YOUR KIT COVID FLU OR COVID 19? FLU. IS THERE ANY LIQUID LEFT IN THE VIAL? YES. WAS THE READY LIGHT ON AND STEADY (SOLID) WHEN YOU STIRRED THE SWAB? YES. 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: BOTH FLASHING. FLU A LED STATUS: BOTH FLASHING. FLU B LED STATUS: BOTH FLASHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1694667 LUCIRA CHECK-IT COVID-19 TEST COVID-19-TEST KIT QJR PFIZER, INC K10A112012233M3

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other