BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCIRA CHECK-IT COVID-19 TEST

    MDR report key: 18333326 · Received December 15, 2023

    Report

    Report Number
    3016521623-2023-00503
    Event Type
    Malfunction
    Date Received
    December 15, 2023
    Date of Event
    November 28, 2023
    Report Date
    December 6, 2023
    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 ISSUES OF "FALSE POSITIVE" AND "INVALID/INVALID AFTER TEST" WERE REPORTED. NOTE THAT THE AFFECTED PRODUCT FOR "FALSE POSITIVE" WAS DETERMINED TO BE EXPIRED AT THE TIME OF USE AND THEREFORE WILL BE INVESTIGATED AS "USE ERROR". PRODUCT IS USED FOR DIAGNOSTIC PURPOSES. NO HARM WAS REPORTED. A RETURN SAMPLE HAS NOT BEEN RECEIVED/EVALUATED. CAPA-000020 IS OPEN TO ADDRESS THE PROCESS FOR EVALUATING RETURN SAMPLES. NO FURTHER EVALUATION IS REQUIRED AT THIS TIME.[?] A DHR REVIEW OF KIT LOT NUMBER K08A112009224M6 WAS PERFORMED; NO NCRS WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THE ISSUE OF "FALSE POSITIVE". HOWEVER, IT SHOULD BE NOTED THAT THE EXPIRATION DATE ASSOCIATED WITH K08A112009224M6 WAS DETERMINED TO BE 20OCT2023; THIS DATE ACCOUNTS FOR THE SHELF-LIFE EXTENSION GRANTED PER CS006, REVA.0. AS THE COMPLAINT WAS RECEIVED 28NOV2023, USE OF AN EXPIRED TEST WAS CONFIRMED. THE INSTRUCTIONS FOR USE (IFU) FOR THE LUCIRA CHECK-IT COVID-19 TEST KIT (INST019 REVE.0) STATES "DO NOT USE KIT COMPONENTS AFTER THEIR EXPIRATION DATE". IF THE USER IS AWARE THAT THE TEST KITS ARE EXPIRED, THE DEVICES SHOULD NOT BE USED. A MOST PROBABLE ROOT CAUSE OF THE ISSUE OF "FALSE POSITIVE" CANNOT BE DETERMINED WITHOUT RETURNED/EVALUATED PRODUCT. EXPECTED DEVICE FUNCTIONALITY CANNOT BE GUARANTEED AFTER THE EXPIRATION DATE. A SUPPLEMENTAL REPORT WILL BE FILED IF ANY FURTHER INVESTIGATION AND/OR ADDITIONAL INFORMATION IS OBTAINED. THIS DEVICE IS MARKETED UNDER EUA (B)(4). THE POTENTIAL HARM RESULTING FROM "INVALID/INVALID AFTER TEST" IS "A DELAY IN TEST RESULTS" AND IS DOCUMENTED IN LUCIRA COVID-19 TEST SYSTEM HAZARD ANALYSIS (RSK053, REVB.0) IN HAZARD IDS #51 AND #52. CAPA-2022-015 WAS OPENED TO INVESTIGATE "INVALID/INVALID AFTER TEST". A DEFINITIVE FAILURE COULD NOT BE DETERMINED, BUT THE MOST PROBABLE ISSUE/FAILURE MODE IS DOCUMENTED IN CAPA-2022-015 AS PIC INHIBITION (POTENTIAL CONTAMINANTS INTRODUCED BY THE SAMPLE VIAL AND SAMPLE VIAL LOT RELEASE TESTING IS FOR LACK OF AMPLIFICATION, BUT DOES NOT INCLUDE ACTUAL AMPLIFICATION OR POSITIVE SPIKES). THE RELEVANT PFMEA RISK IS "INDEX #12" (PFMEA007, REVB.0). ACTIONS WERE IMPLEMENTED AND THE EFFECTIVENESS CHECK IS ONGOING. BASED ON THE INFORMATION ABOVE, NO FURTHER INVESTIGATION IS REQUIRED. MONITORING OF "FALSE POSITIVE" AND "USE ERROR" WILL CONTINUE AND THERE ARE NO ADDITIONAL RECOMMENDED ACTIONS AT THIS POINT.

    Description of Event or Problem · 0

    "CUSTOMER CONTACTED ON 11/28/2023 TO REPORT A FALSE POSITIVE TEST. EVIDENCE** PROVIDED. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N YES. MAY I HAVE YOUR LOT AND TEST KIT #? LOT #: K08A112009224M6. TEST KIT #: 4A6L4Q4W. 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? 1 LUCIRA 3 ANTIGEN. HOW MANY TOTAL TESTS WERE RUN BEFORE GETTING THIS FALSE POSITIVE? 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 19". "CUSTOMER CONTACTED ON 11/28/2023 TO REPORT AN INVALID TEST AFTER 30 MINUTES. EVIDENCE PROVIDED. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N. YES. MAY I HAVE YOUR LOT AND TEST KIT #? LOT #: K08A111505233M2. TEST KIT #: 3A9T1A8N. IS YOUR KIT COVID FLU OR COVID 19? COVID 19. 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
    2302592 LUCIRA CHECK-IT COVID-19 TEST COVID-19 TEST KIT QJR PFIZER INC K08A112009224M6

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other