BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCIRA CHECK-IT COVID-19 TEST

    MDR report key: 18649866 · Received February 6, 2024

    Report

    Report Number
    3016521623-2024-00502
    Event Type
    Malfunction
    Date Received
    February 6, 2024
    Date of Event
    January 26, 2024
    Report Date
    February 5, 2024
    Manufacturer
    PFIZER, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 NEGATIVE" WAS REPORTED. PRODUCT IS USED FOR DIAGNOSTIC PURPOSES. NO HARM(S) WERE REPORTED. REFER TO (B)(4) _INVESTIGATION_02FEB2024.PDF FOR THE COMPLETE INVESTIGATION. BASED ON THE INFORMATION IN THE ATTACHED INVESTIGATION, NO FURTHER INVESTIGATION IS REQUIRED. MONITORING OF "FALSE NEGATIVE" WILL CONTINUE AND THERE ARE NO ADDITIONAL RECOMMENDED ACTIONS AT THIS POINT. A MOST PROBABLE ROOT CAUSE CANNOT BE DETERMINED WITHOUT RETURNED PRODUCT. POTENTIAL ROOT CAUSES INCLUDE BUT ARE NOT LIMITED TO: NO AMPLIFICATION/REDUCED AMPLIFICATION EFFICIENCY (DESIGN DEFECT). ASSAY CONTAMINATION/DEGRADATION (PROCESS FAILURE). IMPROPER STORAGE/HANDLING (USE ERROR).

    Description of Event or Problem · 0

    "CUSTOMER CONTACTED US ON (B)(6) 2024 TO REPORT A FALSE NEGATIVE. EVIDENCE PROVIDED. TEST RAN ON 1/26/2024. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N? YES. LOCATION OF TESTING? INDOOR/OUTDOOR? INDOOR. MAY I HAVE YOUR LOT AND TEST KIT #? LOT #: K10A011307233M8. TEST KIT #: (B)(6). WAS THE TEST COMPLETED ON A FLAT SURFACE? Y/N? YES. WAS THE SWAB ROTATED 5 TIMES IN EACH NOSTRIL? Y/N? YES. 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 NEGATIVE TEST WAS A RETEST(S) COMPLETED? 1-4 HOURS. WHAT TEST DID YOU USE TO CONFIRM THE FALSE NEGATIVE? DID NOT REPLY. HOW MANY TOTAL TESTS WERE RUN BEFORE GETTING THIS FALSE NEGATIVE? 0. 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 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: NEGATIVE::ON".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541755 LUCIRA CHECK-IT COVID-19 TEST COVID 19 TEST KIT QJR PFIZER, INC. K10A011307233M8

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other