BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCIRA CHECK-IT COVID-19 TEST

    MDR report key: 19466836 · Received June 5, 2024

    Report

    Report Number
    3016521623-2024-00522
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    May 25, 2024
    Report Date
    June 4, 2024
    Manufacturer
    PFIZER, INC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. BASED ON A REVIEW OF THE RISK MANAGEMENT FILE FOR THE LUCIRA COVID-19 & FLU TEST KIT, FALSE POSITIVE TEST RESULTS ARE A KNOWN POSSIBLE FAILURE; REFER TO FMEA009 REVC.0, FMEA011 REVC.0, FMEA016 REVB.0, AND FMEA017 REVB.0. RSK062, FMEA009, AND FMEA011 HAVE BEEN REVISED TO REVD.0, REVE.0, AND REVE.0, RESPECTIVELY; HOWEVER, RSK062 REVB.0, FMEA009 REVC.0, AND FMEA011 REVC.0 REMAIN APPLICABLE TO THIS INVESTIGATION DUE TO THE DATE THE PRODUCT WAS COMMERCIALLY MANUFACTURED. POTENTIAL CAUSES AND POTENTIAL HARMS AS LISTED IN THIS INVESTIGATION ARE NOT ALL INCLUSIVE, AS PRODUCT WAS NOT RETURNED FOR EVALUATION. THE FOLLOWING POTENTIAL CAUSES WERE IDENTIFIED IN FMEA009 REVC.0: 91 "TRAPPED AIR ENTERS CHIP DURING FILLING (BUBBLE IN REACTION CHAMBER INTERFERES WITH ASSAY RUN AND IS NOT INVALIDATED)" 123 "REACTION HAS REDUCED REACTION PH AND BUFFERING CAPACITY (REACTION COLOR CAN CHANGE DUE TO LOW LEVEL NON-SPECIFIC AMPLIFICATION)" 135 "PRIMERS BIND TO OTHER PATHOGENS OR HUMAN TARGETS (REACTION AMPLIFIES HUMAN OR CROSS-REACTIVE PATHOGEN DNA/RNA)" 136 "AMPLIFICATION IN ABSENCE OF TARGET VIRUS (FALSE AMPLIFICATION)" 143 "BST ENZYME ACTIVITY AT NON-OPTIMAL TEMPERATURES DURING RAMP (FALSE AMPLIFICATION)" THE FOLLOWING POTENTIAL CAUSES WERE IDENTIFIED IN FMEA011 REVC.0: 4 "TEST KIT IS NOT STORED AT THE RECOMMENDED CONDITIONS (DEVICE EXPOSED TO EXTREME TEMPERATURE OR HUMIDITY)" 31 "USER MOVES DEVICE DURING RUN (SIGNAL PERTURBATIONS)" 37 "USER DROPS DEVICE WHILE RUNNING (FALSE POSITIVE RESULT)" THE FOLLOWING POTENTIAL CAUSES WERE IDENTIFIED IN FMEA016 REVB.0: 14 "LYOP003 AND LYOP024 WITH POSITIVE AMPLIFICATION IS ACCEPTED (AMPLICON CONTAMINATION INTRODUCED TO PMIX)" THE FOLLOWING POTENTIAL CAUSES WERE IDENTIFIED IN FMEA017 REVB.0: 7 "INTERNAL CONTROL AND TARGET ASSAY PELLETS WITH POSITIVE AMPLIFICATION IS ACCEPTED (AMPLICON CONTAMINATION INTRODUCED TO REAG019)" 112 "BOTTLE NOT PLACED IN THE PCR HOOD (VIABLE AIRBORNE PARTICLES LAND ON THE BOTTLES, LEADING TO BACTERIAL CONTAMINATION OF FUTURE ELUTION BUFFER LOTS)" 114 "PCR HOOD MALFUNCTION / INADEQUATE PERFORMANCE (VIABLE AIRBORNE PARTICLES LAND ON THE BOTTLES, LEADING TO BACTERIAL CONTAMINATION OF FUTURE ELUTION BUFFER LOTS)" 147 "AIR ENTERS PUMP SUCTION (FILTER POPS OFF, LEADING TO POTENTIAL BACTERIAL CONTAMINATION INTRODUCED TO ELUTION BUFFER)" THE FOLLOWING POTENTIAL HARMS WERE IDENTIFIED IN RSK062 REVB.0: 11 "ASSAY FALSE AMPLIFICATION RESULTING IN A FALSE POSITIVE TEST RESULT : UNNECESSARY TREATMENT" 24 "FALSE CURVES THAT MIMIC AMPLIFICATION RESULTING IN A FALSE POSITIVE TEST RESULT : UNNECESSARY TREATMENT" 29 "BUBBLES INTERFERE WITH COLORIMETRIC SIGNAL RESULTING IN A FALSE POSITIVE TEST RESULT : UNNECESSARY TREATMENT" 47 "PMIX CONTAMINATED WITH TEMPLATE RESULTING IN A FALSE POSITIVE TEST RESULT : UNNECESSARY TREATMENT" 49 "ELUTION BUFFER CONTAMINATED WITH TEMPLATE RESULTING IN A FALSE POSITIVE TEST RESULT : UNNECESSARY TREATMENT" 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) A SUPPLEMENTAL REPORT WILL BE FILED IF ANY FURTHER INVESTIGATION AND/OR ADDITIONAL INFORMATION IS OBTAINED. THIS DEVICE IS MARKETED UNDER EUA 220490. 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.

    Description of Event or Problem · 0

    "THE CUSTOMER PROVIDED A REVIEW ON AMAZON ON (B)(6) 2024, AND IT WAS PUBLICLY VISIBLE UNTIL (B)(6) 2024. CUSTOMER REPORTED 1 FALSE POSITIVE. NO EVIDENCE WAS PROVIDED ON THE REVIEW. NO MORE INFORMATION COULD BE COLLECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172143 LUCIRA CHECK-IT COVID-19 TEST COVID-19-TEST KIT QJR PFIZER, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other