BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCIRA CHECK-IT COVID-19 TEST

    MDR report key: 18500044 · Received January 11, 2024

    Report

    Report Number
    3016521623-2023-00507
    Event Type
    Malfunction
    Date Received
    January 11, 2024
    Date of Event
    January 2, 2024
    Report Date
    January 10, 2024
    Manufacturer
    PFIZER, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 NEGATIVE" AND "INVALID/INVALID AFTER TEST" WERE REPORTED. NOTE THAT ONE OF THE AFFECTED LOT NUMBERS REPORTED FOR "INVALID/INVALID AFTER TEST" WAS DETERMINED TO BE EXPIRED AT THE TIME OF USE AND WILL THEREFORE BE INVESTIGATED AS "USE ERROR". PRODUCT IS USED FOR DIAGNOSTIC PURPOSES. NO HARM(S) WERE REPORTED. REFER TO (B)(4)_INVESTIGATION_10JAN2024.PDF FOR THE COMPLETE INVESTIGATION. BASED ON THE INFORMATION IN THE ATTACHED INVESTIGATION, NO FURTHER INVESTIGATION IS REQUIRED. MONITORING OF "FALSE NEGATIVE", "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 NEGATIVE" 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). A MOST PROBABLE ROOT CAUSE FOR THE ISSUE OF "INVALID/INVALID AFTER TEST" WITH AN EXPIRED PRODUCT CANNOT BE DETERMINED WITHOUT RETURNED/EVALUATED PRODUCT.

    Description of Event or Problem · 0

    CUSTOMER CONTACTED US ON (B)(6) 2024 TO REPORT A FALSE NEGATIVE. NOT EVIDENCES PROVIDED. THE CUSTOMER DIDN'T SPECIFY ON WHICH DATE THEY RAN THE TEST. CUSTOMER CLAIMED THAT RAN ANOTHER TEST WHERE HE GOT A POSITIVE RESULT. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N YES. MAY I HAVE YOUR LOT AND TEST KIT #? LOT #: K10A013003234M2. TEST KIT #: DNR. 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? 12-24 HOURS. WHAT TEST DID YOU USE TO CONFIRM THE FALSE NEGATIVE? COVID -19 CHECK IT. HOW MANY TOTAL TESTS WERE RUN BEFORE GETTING THIS FALSE NEGATIVE? 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? - 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: DID NOT REPLY. FLU B LED STATUS: DID NOT REPLY". "CUSTOMER CONTACTED US ON 1/2/2024 TO REPORT 4 INVALID RESULT AFTER 30 MINUTES. EVIDENCES PROVIDED. THE CUSTOMER DIDN'T SPECIFY ON WHICH DATE THEY RAN THE TEST. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N YES. MAY I HAVE YOUR LOT AND TEST KIT #? LOT #: K10A013003234M2 / K08A110301233M2. TEST KIT #: DNR. IS THERE ANY LIQUID LEFT IN THE VIAL? YES. WAS THE READY LIGHT BLINKING WHEN YOU STIRRED THE SWAB? NO. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917189 LUCIRA CHECK-IT COVID-19 TEST COVID 19 TEST KIT QJR PFIZER, INC. K10A013003234M2

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other