LUCIRA CHECK-IT COVID-19 TEST
Report
- Report Number
- 3016521623-2023-00508
- Event Type
- Malfunction
- Date Received
- January 22, 2024
- Date of Event
- January 4, 2024
- Report Date
- April 15, 2024
- Manufacturer
- PFIZER, INC
- Product Code
- QJR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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 THERE IS INDICATION OF FAILURE TO FOLLOW INSTRUCTIONS, WHICH WILL BE INVESTIGATED AS "USE ERROR". PRODUCT IS USED FOR DIAGNOSTIC PURPOSES. NO HARM(S) WERE REPORTED. REFER TO (B)(4) INVESTIGATION 11JAN2024. PDF FOR THE COMPLETE INVESTIGATION. 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. 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).
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 THERE IS INDICATION OF FAILURE TO FOLLOW INSTRUCTIONS, WHICH WILL BE INVESTIGATED AS "USE ERROR". 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 (INST035 REVE.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." IT SHOULD BE ADDITIONALLY NOTED THAT FAILURE TO FOLLOW INSTRUCTIONS MAY HAVE AN IMPACT ON DEVICE FUNCTIONALITY; PER STEP 3 OF SECTION B, "MIX SAMPLE BY STIRRING AROUND THE SAMPLE VIAL 15 TIMES. DISCARD SWAB. IMMEDIATELY SNAP CAP CLOSED AND PRESS VIAL DOWN INTO TEST UNIT UNTIL IT CLICKS. READY LIGHT WILL START BLINKING WHEN TEST IS RUNNING", INDICATING THAT THE READY LIGHT SHOULD NOT START BLINKING AND THE TEST SHOULD NOT BE RUNNING UNTIL AFTER THE SWAB IS STIRRED. 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 2 AFFECTED DEVICES (BOTH K09A010908225M1) FOR THE ISSUES OF "FALSE POSITIVE" AND "INVALID/INVALID AFTER TEST". FAILURE ANALYSIS INVESTIGATION FINDING "TEST UNIT: NO ISSUES" WAS CONCLUDED FOR DEVICE 2 (UDI: (B)(4) AND DOES NOT ALIGN WITH THE REPORTED ISSUE OF "FALSE POSITIVE". BASED ON THE INFORMATION OBTAINED DURING FA, THE ISSUE OF "FALSE POSITIVE" CANNOT BE CONFIRMED. FAILURE ANALYSIS INVESTIGATION FINDING "TIC NEGATIVE: NO CAUSE ESTABLISHED" WAS CONCLUDED FOR DEVICE 1 (UDI: (B)(4) AND CAN RESULT IN THE REPORTED ISSUE OF "INVALID/INVALID AFTER TEST". A FAILED (NEGATIVE) CONTROL MAY CAUSE THE DEVICE TO INVALIDATE. A DHR REVIEW OF KIT LOT NUMBER: K09A010908225M1 (EXPIRATION DATE: 07JAN2024) AND DEVICE MODULE (DM) LOT NUMBER: T00903110722CD1 (DHR 2207128) INCLUDED IN THE KITTED PRODUCT WAS PERFORMED; NO NCRS WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THE ISSUES OF "FALSE POSITIVE" OR "INVALID/INVALID AFTER TEST". THE POTENTIAL HARM RESULTING FROM "FALSE POSITIVE" CANNOT BE IDENTIFIED, AS THE COMPLAINT WAS NOT CONFIRMED. 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". THE POTENTIAL HARM RESULTING FROM "INVALID/INVALID AFTER TEST" IS "A DELAY IN TEST RESULTS" AND IS DOCUMENTED IN LUCIRA COVID-19, FLU A AND FLU B SYSTEM HAZARD ANALYSIS (RSK062, REVB.0) IN HAZARD ID 9. 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. CAPA: 2022-015 WAS OPENED TO INVESTIGATE "INVALID/INVALID AFTER TEST". HOWEVER, THE MOST PROBABLE ROOT CAUSE AS DOCUMENTED IN CAPA: 2022-015 IS UNRELATED TO THE OBSERVED FA FINDING. ACTIONS WERE IMPLEMENTED AND THE EFFECTIVENESS CHECK IS ONGOING. 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", "INVALID/INVALID AFTER TEST" AS IT RELATES TO THE FA FINDING, AND "USE ERROR" WILL CONTINUE AND THERE ARE NO ADDITIONAL RECOMMENDED ACTIONS AT THIS POINT. FAILURE ANALYSIS INVESTIGATION FINDING "TEST UNIT: NO ISSUES" WAS CONCLUDED FOR K09A010908225M1 (UDI: (B)(4) AND DOES NOT ALIGN WITH THE REPORTED ISSUE OF "FALSE POSITIVE". AS A RESULT, A MOST PROBABLE ROOT CAUSE CANNOT BE DETERMINED, AS THE ISSUE OF "FALSE POSITIVE" CANNOT BE CONFIRMED. FAILURE ANALYSIS INVESTIGATION FINDING " TIC NEGATIVE: NO CAUSE ESTABLISHED" WAS CONCLUDED FOR K09A010908225M1 (UDI: (B)(4) AND CAN RESULT IN THE REPORTED ISSUE OF "INVALID/INVALID AFTER TEST". UPDATED FIELDS: B4: CHANGED TO 04/15/2024. D3: ADDRESS CHANGED. D9: DEVICE SENT BACK WITH DATE. G1: UPDATED CONTACT INFORMATION. G6: FOLLOWUP. H6: CODING CHANGED.
1) CUSTOMER CONTACTED US ON (B)(6) 2024 TO REPORT 1 FALSE POSITIVE RESULT FOR FLU A. EVIDENCE PROVIDED. TEST WAS PERFORMED ON (B)(6) 2024. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N YES MAY I HAVE YOUR LOT AND TEST KIT #? LOT #: K09A010908225M1 TEST KIT #: 5A0A0N1D 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? THE SAME KIND -- LUCIRA COVID/FLU TEST. 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 FLU PLEASE PROVIDE THE STATUS OF EACH LED STATUS? (ONLY FOR COVID/ FLU KITS) COVID LED STATUS: NEGATIVE::ON FLU A LED STATUS: POSITIVE::ON FLU B LED STATUS: NEGATIVE::ON" 2) CUSTOMER CONTACTED US ON (B)(6) 2024 TO REPORT 1 INVALID RESULT - AFTER 30 MINUTES. EVIDENCE PROVIDED. TEST WAS PERFORMED ON (B)(6) 2023. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N YES MAY I HAVE YOUR LOT AND TEST KIT #? LOT #: K09A010908225M1 TEST KIT #: 5A0A0G8J IS YOUR KIT COVID FLU OR COVID 19? COVID FLU IS THERE ANY LIQUID LEFT IN THE VIAL? YES [?] WAS THE READY LIGHT BLINKING WHEN YOU STIRRED THE SWAB? YES 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 PLEASE PROVIDE THE STATUS OF EACH LED STATUS? (ONLY FOR COVID FLU KITS) COVID LED STATUS: DID NOT REPLY, FLU A LED STATUS: DID NOT REPLY, FLU B LED STATUS: DID NOT REPLY.
"CUSTOMER CONTACTED US ON (B)(6) 2024 TO REPORT 1 FALSE POSITIVE RESULT FOR FLU A. EVIDENCE PROVIDED. TEST WAS PERFORMED ON (B)(6) 2024. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N. YES. MAY I HAVE YOUR LOT AND TEST KIT #? LOT#: K09A010908225M1, TEST KIT#: 5A0A0N1D. 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? THE SAME KIND -- LUCIRA COVID/FLU TEST. 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 FLU. PLEASE PROVIDE THE STATUS OF EACH LED STATUS? (ONLY FOR COVID/ FLU KITS) COVID LED STATUS: NEGATIVE: ON, FLU A LED STATUS: POSITIVE: ON, FLU B LED STATUS: NEGATIVE: ON". "CUSTOMER CONTACTED US ON (B)(6) 2024 TO REPORT 1 INVALID RESULT - AFTER 30 MINUTES. EVIDENCE PROVIDED. TEST WAS PERFORMED ON (B)(6) 2023. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N. YES. MAY I HAVE YOUR LOT AND TEST KIT #? LOT#: K09A010908225M1, TEST KIT#: 5A0A0G8J. IS YOUR KIT COVID FLU OR COVID 19? COVID FLU [?] IS THERE ANY LIQUID LEFT IN THE VIAL? YES [?] WAS THE READY LIGHT BLINKING WHEN YOU STIRRED THE SWAB? YES. 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[?] PLEASE PROVIDE THE STATUS OF EACH LED STATUS? (ONLY FOR COVID FLU KITS). COVID LED STATUS: DID NOT REPLY, FLU A LED STATUS: DID NOT REPLY, FLU B LED STATUS: DID NOT REPLY".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 403722 | LUCIRA CHECK-IT COVID-19 TEST | COVID-19-TEST KIT | QJR | PFIZER, INC | K09A010908225M1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |