BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCIRA CHECK-IT COVID-19 TEST

    MDR report key: 19105257 · Received April 15, 2024

    Report

    Report Number
    3016521623-2024-00517
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    April 5, 2024
    Report Date
    April 15, 2024
    Manufacturer
    PFIZER, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. A DHR REVIEW CANNOT BE COMPLETED AS LOT INFORMATION WAS NOT PROVIDED. 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 LUCIRA BY PFIZER ON 04/05/2024 AND THE TICKET WAS REVIEWED BY US ON 4/10/2024. THE DATE WHEN THE TEST WAS TAKEN WAS NOT PROVIDED. CUSTOMER CONTACTED US TO REPORT A FALSE POSITIVE, THE CUSTOMER USED BINAX NOW TEST, FOLLOWED BY PEDIATRICIAN TEST THE NEXT DAY TO CLARIFY THAT IT WAS A FALSE POSITIVE. V# WAS NOT PROVIDED. EVIDENCE WAS NOT PROVIDED. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N. YES. MAY I HAVE YOUR LOT AND TEST KIT #? LOT #: DNR. TEST KIT #: DNR. 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? BINAX NOW TEST, FOLLOWED BY PEDIATRICIAN TEST THE NEXT DAY. 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 TREATMENT WAS NEEDED. 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: POSITIVE::ON. FLU A LED STATUS: NEGATIVE::OFF. FLU B LED STATUS: NEGATIVE::OFF. NOTE: CUSTOMER CONTACTED PFIZER CONTACT CENTER ON 5TH APRIL 2024. HOWEVER, THE LUCIRA BY PFIZER SUPPORT TEAM WAS MADE AWARE ON 10TH APRIL 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376289 LUCIRA CHECK-IT COVID-19 TEST COVID 19 TEST KIT QJR PFIZER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other