LUCIRA CHECK-IT COVID-19 TEST
Report
- Report Number
- 3016521623-2023-00490
- Event Type
- Malfunction
- Date Received
- September 15, 2023
- Date of Event
- August 31, 2023
- Report Date
- April 17, 2024
- Manufacturer
- PFIZER, INC.
- Product Code
- QJR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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 WAS REPORTED. A DHR REVIEW OF KIT LOT NUMBER K08A111509224M2 (EXPIRATION DATE (B)(6) 2023) WAS PERFORMED; NO NCRS WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THE ISSUE OF "FALSE POSITIVE". BASED ON A REVIEW OF THE RISK MANAGEMENT FILE FOR THE LUCIRA COVID-19 TEST KIT, FALSE POSITIVE TEST RESULTS ARE A KNOWN POSSIBLE FAILURE; REFER TO FMEA001 REVC.0, FMEA004 REVB.0, FMEA016 REVB.0, AND FMEA017 REVB.0. 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 FMEA001 REVC.0: - 65 "PRIMERS BIND TO OTHER PATHOGENS OR HUMAN TARGETS (REACTION AMPLIFIES HUMAN OR CROSS-REACTIVE PATHOGEN DNA/RNA)". - 79 "REACTION HAS REDUCED REACTION PH AND BUFFERING CAPACITY (REACTION COLOR CAN CHANGE DUE TO LOW LEVEL NON-SPECIFIC AMPLIFICATION)". - 96 "TRAPPED AIR ENTERS CHIP DURING FILLING (BUBBLE IN REACTION CHAMBER INTERFERES WITH ASSAY RUN AND IS NOT INVALIDATED)". - 139 "AMPLIFICATION IN ABSENCE OF SARS-COV-2 VIRUS (COVID FALSE AMPLIFICATION)". - 143 "BST ENZYME ACTIVITY AT NON OPTIMAL TEMPERATURES DURING RAMP (COVID FALSE AMPLIFICATION)". THE FOLLOWING POTENTIAL CAUSES WERE IDENTIFIED IN FMEA004 REVB.0: - 4 "TEST KIT IS NOT STORED AT THE RECOMMENDED CONDITIONS (DEVICE EXPOSED TO EXTREME TEMPERATURE OR HUMIDITY)". - 29 "USER MOVES DEVICE DURING RUN (SIGNAL PERTURBATIONS)". - 36 "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 RSK053 REVB.0: - 11 "ASSAY FALSE AMPLIFICATION RESULTING IN A FALSE POSITIVE TEST RESULT : UNNECESSARY TREATMENT". - 23 "FALSE CURVES THAT MIMIC AMPLIFICATION RESULTING IN A FALSE POSITIVE TEST RESULT : UNNECESSARY TREATMENT". - 28 "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". - 53 "ELUTION BUFFER CONTAMINATED WITH MICROBE 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 (B)(4). BASED ON THE INFORMATION ABOVE, NO FURTHER INVESTIGATION IS REQUIRED.
THIS INVESTIGATION IS BASED ON THE AVAILABLE INFORMATION CAPTURED IN THE COMPLAINT DETAILS. THE ISSUE OF "FALSE POSITIVE" WAS REPORTED. NOTE THAT THERE IS INDICATION OF FAILURE TO FOLLOW INSTRUCTIONS, WHICH WILL BE INVESTIGATED AS "USE ERROR". PRODUCT IS USED FOR DIAGNOSTIC PURPOSES. NO HARM WAS REPORTED. IT SHOULD BE NOTED THAT FAILURE TO FOLLOW INSTRUCTIONS MAY HAVE AN IMPACT ON DEVICE FUNCTIONALITY; REFER TO THE INSTRUCTIONS FOR USE (IFU) FOR THE LUCIRA CHECK-IT COVID-19 TEST KIT (INST019 REVE.0). PER STORAGE AND HANDLING, "TEST KITS MUST ALWAYS BE STORED AT AN AMBIENT TEMPERATURE (15-30°C / 59-86°F)." AND PER PRINCIPLES OF THE PROCEDURES, "THE SAMPLE VIAL CONTAINS AN ELUTION BUFFER THAT ALLOWS THE SWAB CONTENTS TO BE ELUTED AND LYSED AT ROOM TEMPERATURE, RELEASING VIRAL AND HUMAN RNA FOR DOWNSTREAM DETECTION", INDICATING THAT USERS SHOULD PERFORM THE TEST INDOORS. THE USER SHOULD READ AND PERFORM THE APPROPRIATE STEPS AS OUTLINED IN THE IFU FOR THE DEVICE TO FUNCTION AS INTENDED. FAILURE ANALYSIS (FA) WAS PERFORMED ON 1 AFFECTED DEVICE (K08A111509224M2) FOR THE ISSUE OF "FALSE POSITIVE". FAILURE ANALYSIS INVESTIGATION FINDING "PIC NEGATIVE: NO CAUSE ESTABLISHED" WAS CONCLUDED AND MAY RESULT IN THE REPORTED ISSUE OF "FALSE POSITIVE". OBSERVATIONS FROM FA DETERMINED THAT THE COVID-19 VIRUS WAS DETECTED IN THE TEST CHAMBER IN ADDITION TO THE PIC NEGATIVE VALUE. WHILE A POSITIVE RESULT IS EXPECTED UNDER THESE CONDITIONS, DUE TO THE PIC FAILURE, A TRUE POSITIVE RESULT CANNOT BE CONFIRMED, THUS LEAVING POTENTIAL FOR A FALSE POSITIVE RESULT. A DHR REVIEW OF KIT LOT NUMBER: K08A111509224M2 (EXPIRATION DATE: 21SEP2023) AND DEVICE MODULE (DM) LOT NUMBER: T00803310322BD8 (DHR 2204075) INCLUDED IN THE KITED PRODUCT WAS PERFORMED; NO NCRS WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THE ISSUE OF "FALSE POSITIVE". THE POTENTIAL HARM RESULTING FROM "FALSE POSITIVE" IS "UNNECESSARY TREATMENT" AND IS DOCUMENTED IN THE LUCIRA COVID-19 TEST SYSTEM HAZARD ANALYSIS (RSK053, REVB.0) IN HAZARD ID 11. A SUPPLEMENTAL REPORT WILL BE FILED IF ANY FURTHER INVESTIGATION AND/OR ADDITIONAL INFORMATION IS OBTAINED. THIS DEVICE IS MARKETED UNDER EUA: (B)(4). 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. UPDATED FIELDS: D9: UPDATED DEVICE RECEIVED AND DATE. G1: UPDATED TO PFIZER NEW ADDRESS FIELD. G3: UPDATED TO PFIZER NEW ADDRESS FIELD. G6: UPDATED FOLLOW-UP. H6: UPDATED CODING.
MOST PROBABLE ROOT CAUSE: FAILURE ANALYSIS INVESTIGATION FINDING "CHAMBER: INCORRECT REACTION" WAS CONCLUDED FOR K08A111509224M2 AND MAY RESULT IN THE REPORTED ISSUE OF "FALSE POSITIVE".
ATTACHED PDF EMAIL DOCUMENT CONFIRMING NUMBER OF DEVICES AFFECTED TO BE ONE DEVICE. CAPA OPENED DUE TO LATE SUBMISSION- CAPA-000061: FAILURE OF REPORTABLE COMPLAINT SUPPLEMENTAL SUBMISSION.
"CUSTOMER CONTACTED US ON (B)(6) 2023 TO REPORT A FALSE POSITIVE RESULT. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N: YES. MAY I HAVE YOUR LOT AND TEST KIT #? LOT #: K08A111509224M2. TEST KIT #: 4A6J1J9W. LOCATION OF TESTING? INDOOR/OUTDOOR: OUTDOOR. 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? 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 POSITIVE TEST WAS A RETEST(S) COMPLETED? 4-12 HOURS. WHAT TEST DID YOU USE TO CONFIRM THE FALSE POSITIVE? 2 LUCIRA TEST KITS. 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? NO SHE DOES NOT HAVE SYMPTOMS. IS YOUR KIT COVID/ FLU OR COVID 19? COVID 19.
CUSTOMER CONTACTED US ON (B)(6) 2023 TO REPORT A FALSE POSITIVE RESULT. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/ N, YES. MAY I HAVE YOUR LOT AND TEST KIT #? LOT#: K08A111509224M2, TEST KIT#: 4A6J1J9W. LOCATION OF TESTING? INDOOR/OUTDOOR, OUTDOOR. 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? 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 POSITIVE TEST WAS A RETEST(S) COMPLETED? 4-12 HOURS. WHAT TEST DID YOU USE TO CONFIRM THE FALSE POSITIVE? 2 LUCIRA TEST KITS. 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? NO, SHE DOES NOT HAVE SYMPTOMS. IS YOUR KIT COVID/ FLU OR COVID 19? COVID 19. THIS SUPPLEMENTAL IS BEING SUBMITTED BECAUSE THE PRODUCT WAS RECEIVED FOR INVESTIGATION.
CUSTOMER CONTACTED US ON (B)(6) 2023 TO REPORT A FALSE POSITIVE RESULT. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N YES. MAY I HAVE YOUR LOT AND TEST KIT #? LOT #: K08A111509224M2 TEST KIT #: 4A6J1J9W. LOCATION OF TESTING? INDOOR/OUTDOOR OUTDOOR. 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? 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 POSITIVE TEST WAS A RETEST(S) COMPLETED? 4-12 HOURS. WHAT TEST DID YOU USE TO CONFIRM THE FALSE POSITIVE? 2 LUCIRA TEST KITS. 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? NO SHE DOES NOT HAVE SYMPTOMS. IS YOUR KIT COVID/ FLU OR COVID 19? COVID 19. THIS SUPPLEMENTAL IS BEING SUBMITTED BECAUSE THE PRODUCT WAS EVALUATED FURTHER.
"CUSTOMER CONTACTED US ON 08/31/2023 TO REPORT A FALSE POSITIVE RESULT. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N YES. MAY I HAVE YOUR LOT AND TEST KIT #? LOT #: K08A111509224M2. TEST KIT #: 4A6J1J9W. LOCATION OF TESTING? INDOOR/OUTDOOR OUTDOOR. 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? 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 POSITIVE TEST WAS A RETEST(S) COMPLETED? 4-12 HOURS. WHAT TEST DID YOU USE TO CONFIRM THE FALSE POSITIVE? 2 LUCIRA TEST KITS. 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? NO SHE DOES NOT HAVE SYMPTOMS. IS YOUR KIT COVID/ FLU OR COVID 19? COVID 19".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 328408 | LUCIRA CHECK-IT COVID-19 TEST | COVID 19 TEST KIT | QJR | PFIZER, INC. | K08A111509224M2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |