BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCIRA CHECK-IT COVID-19 TEST

    MDR report key: 19656347 · Received July 2, 2024

    Report

    Report Number
    3016521623-2024-00529
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    June 23, 2024
    Report Date
    July 2, 2024
    Manufacturer
    PFIZER, INC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS BASED ON THE AVAILABLE INFORMATION CAPTURED IN THE COMPLAINT DETAILS. THE ISSUE OF "FALSE POSITIVE" WAS REPORTED. 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" 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).

    Description of Event or Problem · 0

    CUSTOMER CONTACTED US ON 6/23/2024, WITH AN EMAIL THAT WENT TO OUR SPAM FOLDER, AND WAS RETRIEVED NEXT DAY. THE CUSTOMER IS REPORTING A FALSE POSITIVE RESULT FOR FLU A ONLY. IT IS NOT CLEAR THE DATES FOR THE TEST USE. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N: YES. MAY I HAVE YOUR LOT AND TEST KIT #? LOT #: K10A110102243M5. TEST KIT #: 3A4K1J9M. LOCATION OF TESTING? INDOOR/OUTDOOR: DID NOT REPLY. WAS THE TEST COMPLETED ON A FLAT SURFACE? Y/N: DID NOT REPLY. WAS THE SWAB ROTATED 5 TIMES IN EACH NOSTRIL? Y/N: DID NOT REPLY. WERE YOU 6 FEET FROM ANOTHER PERSON WHEN TAKING THE TEST? DID NOT REPLY. WERE YOU EXPOSED TO COVID WITH IN THE PREVIOUS 24 HOURS OF TESTING? DID NOT REPLY. WAS THE VIAL LIQUID PURPLE IN COLOR? Y/N: YES. WAS THE TEST MOVED WHILE IT WAS RUNNING? Y/N: DID NOT REPLY. HOW SOON AFTER THE INITIAL POSITIVE TEST WAS A RETEST(S) COMPLETED? DID NOT REPLY. WHAT TEST DID YOU USE TO CONFIRM THE FALSE POSITIVE? DNR. 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? DNR. 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: POSITIVE: ON. FLU B LED STATUS: NEGATIVE: ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756553 LUCIRA CHECK-IT COVID-19 TEST COVID-19-TEST KIT QJR PFIZER, INC K10A110102243M5

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other