BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCIRA CHECK-IT COVID-19 TEST

    MDR report key: 19467797 · Received June 5, 2024

    Report

    Report Number
    3016521623-2024-00523
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    May 27, 2024
    Report Date
    June 24, 2024
    Manufacturer
    PFIZER, INC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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_04JUN2024.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).

    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. NOTE THAT IT IS RECOMMENDED FOR THE USER TO CONTACT THEIR HEALTHCARE PROVIDER UPON RECEIVING A SUSPECTED FALSE POSITIVE RESULT. REFER TO THE INSTRUCTIONS FOR USE (IFU) FOR THE LUCIRA COVID-19 & FLU HOME TEST (INST095 REVB.0). PER STEP 4 (IF THE TEST IS POSITIVE) OF SECTION B, "THERE IS A VERY SMALL CHANCE THAT THIS TEST CAN GIVE A POSITIVE RESULT THAT IS WRONG (A FALSE POSITIVE). YOUR HEALTHCARE PROVIDER WILL WORK WITH YOU TO DETERMINE HOW BEST TO CARE FOR YOU BASED ON YOUR TEST RESULTS ALONG WITH MEDICAL HISTORY AND YOUR SYMPTOMS." CAPA-000069 IS OPEN AND ONGOING TO INVESTIGATE AN UPTICK IN NONCONFORMANCES (NCRS) DURING LOT RELEASE DUE TO "FALSE POSITIVE". POTENTIAL IMPACT TO PRODUCT IN THE FIELD IS UNDER INVESTIGATION, AS THE ASSOCIATED NCRS ARE PENDING FINAL DISPOSITION INCLUDING THE FINAL PRODUCT FAILURE MODE. FAILURE ANALYSIS (FA) WAS PERFORMED ON 1 AFFECTED DEVICE (K10A110102243M6) FOR THE ISSUE OF "FALSE POSITIVE". REFER TO ATTACHED FILE- (B)(4). FAILURE ANALYSIS INVESTIGATION FINDING "TEST UNIT: OBSERVED ISSUE DOESN'T MATCH WITH COMPLAINT" WAS CONCLUDED. BASED ON THE INFORMATION OBTAINED DURING FA, THE REPORTED ISSUE OF "FALSE POSITIVE" CANNOT BE CONFIRMED. A DHR REVIEW OF KIT LOT NUMBER K10A110102243M6 (EXPIRATION DATE 17JUN2025) WAS PERFORMED; NO NCRS WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THE ISSUE OF "FALSE POSITIVE". THE POTENTIAL HARM RESULTING FROM "FALSE POSITIVE" CANNOT BE IDENTIFIED, AS A MOST PROBABLE ROOT CAUSE WAS NOT DETERMINED. REFER TO THE LUCIRA COVID-19, FLU A AND FLU B SYSTEM HAZARD ANALYSIS (RSK062, REVB.0) FOR A LIST OF ALL POTENTIAL HARMS RELATED TO "FALSE POSITIVE". RSK062 HAS BEEN REVISED TO REVD.0; HOWEVER, RSK062 REVB.0 REMAINS APPLICABLE TO THIS INVESTIGATION DUE TO THE DATE THE PRODUCT WAS COMMERCIALLY MANUFACTURED. BASED ON THE INFORMATION ABOVE, NO FURTHER INVESTIGATION IS REQUIRED. MONITORING OF "FALSE POSITIVE" WILL CONTINUE AND THERE ARE NO ADDITIONAL RECOMMENDED ACTIONS AT THIS POINT. FAILURE ANALYSIS INVESTIGATION FINDING "TEST UNIT: OBSERVED ISSUE DOES NOT MATCH THE COMPLAINT" WAS CONCLUDED FOR K10A110102243M6. AS A RESULT, THE REPORTED ISSUE OF "FALSE POSITIVE" CANNOT BE CONFIRMED. UPDATED FIELDS: B4- DATE OF REPORT. E1- CONTACT INFORMATION. H6- CODING. H11-NARRARIVE. ADDITIONAL ATTACHMENTS.

    Description of Event or Problem · 0

    CUSTOMER CONTACTED ON (B)(6) 2024 TO REPORT A FALSE POSITIVE TEST. EVIDENCE OF THE TEST PROVIDED. NO INFORMATION WHEN THE TEST WAS RAN. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N YES. MAY I HAVE YOUR LOT AND TEST KIT #?. LOT #: K10A110102243M6. TEST KIT #: 3A4K2B1E. 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? 12-24 HOURS. WHAT TEST DID YOU USE TO CONFIRM THE FALSE POSITIVE? ANTIGEN TESTS AND PCR TEST. HOW MANY TOTAL TESTS WERE RUN BEFORE GETTING THIS FALSE POSITIVE? 0. 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? I AM FINE. MY PCR WAS NEGATIVE, NO COVID DETECTED. 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::ON. FLU B LED STATUS: NEGATIVE::ON.

    Description of Event or Problem · 0

    "CUSTOMER CONTACTED ON (B)(6) 2024 TO REPORT 1 INVALID RESULT FALSE POSITIVE FOR FLU B. EVIDENCE PROVIDED. TEST RAN ON (B)(6) 2024. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N YES MAY I HAVE YOUR LOT AND TEST KIT #? LOT #: K10A110102243M6 TEST KIT #: 3A4K2W3F 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? LUCIRA BYE PFIZER COVID AND FLU HOW MANY TOTAL TESTS WERE RUN BEFORE GETTING THIS FALSE POSITIVE? 1[?] 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: POSITIVE::ON" ADDITIONAL FOLLOW-UP INFORMATION FROM CUSTOMER SUPPORT: CUSTOMER SUPPORT TEAM CONFIRMED THAT THE USED A TEST AND FLU B POSITIVE LIGHT WAS ON, THEN USER STATED THAT SHE TOOK A SECOND TEST AND THE RESULT WAS NEGATIVE FOR FLU B DESPITE THE EVIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524160 LUCIRA CHECK-IT COVID-19 TEST COVID-19-TEST KIT QJR PFIZER, INC K10A110102243M6

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other