BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCIRA COVID-19 TEST

    MDR report key: 19950481 · Received August 9, 2024

    Report

    Report Number
    3016521623-2024-00531
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    August 2, 2024
    Report Date
    August 9, 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 ISSUE OF "FALSE POSITIVE" WAS REPORTED. PRODUCT IS USED FOR DIAGNOSTIC PURPOSES. NO HARM(S) WERE REPORTED. REFER TO (B)(4) INVESTIGATION_08AUG2024.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 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 08/02/2024 TO REPORT A FALSE POSITIVE RESULT. AS PER THE CUSTOMER, SHE CONFIRMED THE RESULT WITH A PCR AND 2 ANTIGEN HOME TESTS. CUSTOMER REFUSED TO PROVIDE LOT # AND TEST KIT #. SHE DID NOT PROVIDE MORE DETAILS ABOUT THE TEST KIT. CUSTOMER ONLY MENTIONED THAT WAS THE LUCIRA COVID HOME TEST. CUSTOMER DID NOT SPECIFY WHEN THE TEST KIT WAS RUN. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N DID NOT REPLY MAY I HAVE YOUR LOT AND TEST KIT #? LOT #: DNR TEST KIT #: DNR 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 DID NOT REPLY 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? PCR AND 2 ANTIGEN HOME TEST HOW MANY TOTAL TESTS WERE RUN BEFORE GETTING THIS FALSE POSITIVE? 0 DID THE PERSON TESTED, CONTACT A HEALTHCARE PROVIDER? Y/N DNR IF YES, HOW IS THE PERSON TESTED DOING? IS THE PERSON TESTED UNDERGOING ANY TREATMENT? DNR IS YOUR KIT COVID/ FLU OR COVID 19? DID NOT REPLY PLEASE PROVIDE THE STATUS OF EACH LED STATUS? (ONLY FOR COVID/ FLU KITS) COVID LED STATUS: - POSITIVE FLU A LED STATUS: - DNR FLU B LED STATUS: - DNR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2205187 LUCIRA COVID-19 TEST COVID 19 TEST KIT QJR PFIZER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other