LUCIRA CHECK-IT COVID-19 TEST
Report
- Report Number
- 3016521623-2023-00500
- Event Type
- Malfunction
- Date Received
- November 30, 2023
- Date of Event
- November 17, 2023
- Report Date
- April 12, 2024
- Manufacturer
- PFIZER, INC.
- Product Code
- QJR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WY, 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. FAILURE ANALYSIS (FA) WAS PERFORMED ON 1 AFFECTED DEVICE (K10A110912223M5) FOR THE ISSUE OF "FALSE POSITIVE". REFER TO ATTACHED FILE-012975, FILE-012976, AND FILE-014504. FAILURE ANALYSIS INVESTIGATION FINDING "CHAMBER: BUBBLE(S)" WAS CONCLUDED AND CAN RESULT IN THE REPORTED ISSUE OF "FALSE POSITIVE". BUBBLES IN THE CHAMBERS CAN INTERFERE WITH THE COLORIMETRIC SIGNAL AND MIMIC DATA CURVES THAT WOULD TYPICALLY INDICATE AMPLIFICATION IN THE RESPECTIVE CHAMBERS, EVEN IF THE TARGET VIRUS IS NOT ACTUALLY PRESENT. A DHR REVIEW OF KIT LOT NUMBER K10A110912223M5 (EXPIRATION DATE 27MAR2024) AND DEVICE MODULE (DM) LOT NUMBER T01003280922BD2 (DHR 2210129) 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 LUCIRA COVID-19, FLU A AND FLU B SYSTEM HAZARD ANALYSIS (RSK062, REVB.0) IN HAZARD IDS 24 AND 29. 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. 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" WILL CONTINUE AND THERE ARE NO ADDITIONAL RECOMMENDED ACTIONS AT THIS POINT. FAILURE ANALYSIS INVESTIGATION FINDING "CHAMBER: BUBBLE(S)" WAS CONCLUDED FOR K10A110912223M5 AND CAN RESULT IN THE REPORTED ISSUE OF "FALSE POSITIVE". UPDATED FIELDS: G1- UPDATED NAME AND PFIZER NEW ADDRESS FIELD. G3-UPDATED TO PFIZER NEW ADDRESS FIELD. G6-UPDATED FOLLOW-UP. H6-UPDATED CODING.
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_27NOV2023.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/EVALUATED 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 ISSUE OF "FALSE POSITIVE" WAS REPORTED. PRODUCT IS USED FOR DIAGNOSTIC PURPOSES. NO HARM WAS REPORTED. FAILURE ANALYSIS (FA) WAS PERFORMED ON 1 AFFECTED DEVICE (K10A110912223M5) FOR THE ISSUE OF "FALSE POSITIVE". REFER TO ATTACHED (B)(4). FAILURE ANALYSIS INVESTIGATION FINDING "TEST UNIT: NO ISSUES" WAS CONCLUDED 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. A DHR REVIEW OF KIT LOT NUMBER K10A110912223M5 (EXPIRATION DATE 27MAR2024) 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 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". 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. A SUPPLEMENTAL REPORT WILL BE FILED IF ANY FURTHER INVESTIGATION AND/OR ADDITIONAL INFORMATION IS OBTAINED. THIS DEVICE IS MARKETED UNDER (B)(4). 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: NO ISSUES" WAS CONCLUDED FOR K10A110912223M5 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.
CUSTOMER SUBMITTED THIS COMPLAINT ON 11/17/2023 TO THE MANUFACTURER. THEREFORE, THE AWARE DATE FOR THIS COMPLAINT IS 11/17/2023. AS A RESULT OF TECHNICAL PROBLEM IN ZENDESK THE CUSTOMER SUPPORT TEAM ENTERED THE COMPLAINT ON 11/23/2023 AND THIS DATE IS CONSIDERED AS COMPLAINT DATE RECEIVED. AS PER CUSTOMER THE TEST CAME UP AS FLU B POSITIVE WITHIN 10 MINUTES. CUSTOMER ENDED UP RUNNING A RAPID ANTIGEN TEST THAT WAS SPECIFIC FOR SARS-COV-2, FLU A, FLU B, AND RSV. THAT WAS NEGATIVE AND THEN HE RAN ANOTHER ONE OF OUR TESTS AND THAT CAME BACK NEGATIVE FOR ALL THREE ANALYTES. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N. DID NOT REPLY. MAY I HAVE YOUR LOT AND TEST KIT #? LOT #: K10A110912223M5. TEST KIT #: 3B9B2V0B. WAS THE TEST COMPLETED ON A FLAT SURFACE? Y/N DID NOT REPLY. WAS THE SWAB ROTATED 5 TIMES IN EACH NOSTRIL? Y/N DID NOT REPLY. WERE YOU 6 FEET FROM ANOTHER PERSON WHEN TAKING THE TEST? DID NOT REPLY. WERE YOU EXPOSED TO COVID WITH IN THE PREVIOUS 24 HOURS OF TESTING? DID NOT REPLY. WAS THE VIAL LIQUID PURPLE IN COLOR? Y/N DID NOT REPLY. WAS THE TEST MOVED WHILE IT WAS RUNNING? Y/N DID NOT REPLY. HOW SOON AFTER THE INITIAL POSITIVE TEST WAS A RETEST(S) COMPLETED? DID NOT REPLY. WHAT TEST DID YOU USE TO CONFIRM THE FALSE POSITIVE? A RAPID ANTIGEN TEST THAT WAS SPECIFIC FOR SARS-COV-2, FLU A, FLU B, AND RSV, AND A SECOND 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 DNR. IF YES, HOW IS THE PERSON TESTED DOING? IS THE PERSON TESTED UNDERGOING ANY TREATMENT? DNR. 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. THIS IS A SECOND SUPPLEMENTAL DUE TO ADDITIONAL INFORMATION.
CUSTOMER SUBMITTED THIS COMPLAINT ON 11/17/2023 TO THE MANUFACTURER. THEREFORE, THE AWARE DATE FOR THIS COMPLAINT IS 11/17/2023. AS A RESULT OF TECHNICAL PROBLEM IN ZENDESK THE CUSTOMER SUPPORT TEAM ENTERED THE COMPLAINT ON (B)(6) 2023 AND THIS DATE IS CONSIDERED AS COMPLAINT DATE RECEIVED. AS PER CUSTOMER THE TEST CAME UP AS FLU B POSITIVE WITHIN 10 MINUTES. CUSTOMER ENDED UP RUNNING A RAPID ANTIGEN TEST THAT WAS SPECIFIC FOR SARS-COV-2, FLU A, FLU B, AND RSV. THAT WAS NEGATIVE AND THEN HE RAN ANOTHER ONE OF OUR TESTS AND THAT CAME BACK NEGATIVE FOR ALL THREE ANALYTES. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N DID NOT REPLY. MAY I HAVE YOUR LOT AND TEST KIT #? LOT #: K10A110912223M5. TEST KIT #: 3B9B2V0B. WAS THE TEST COMPLETED ON A FLAT SURFACE? Y/N DID NOT REPLY. WAS THE SWAB ROTATED 5 TIMES IN EACH NOSTRIL? Y/N DID NOT REPLY. WERE YOU 6 FEET FROM ANOTHER PERSON WHEN TAKING THE TEST? DID NOT REPLY. WERE YOU EXPOSED TO COVID WITH IN THE PREVIOUS 24 HOURS OF TESTING? DID NOT REPLY. WAS THE VIAL LIQUID PURPLE IN COLOR? Y/N DID NOT REPLY. WAS THE TEST MOVED WHILE IT WAS RUNNING? Y/N DID NOT REPLY. HOW SOON AFTER THE INITIAL POSITIVE TEST WAS A RETEST(S) COMPLETED? DID NOT REPLY. WHAT TEST DID YOU USE TO CONFIRM THE FALSE POSITIVE? A RAPID ANTIGEN TEST THAT WAS SPECIFIC FOR SARS-COV-2, FLU A, FLU B, AND RSV, AND A SECOND 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 DNR. IF YES, HOW IS THE PERSON TESTED DOING? IS THE PERSON TESTED UNDERGOING ANY TREATMENT? - DNR. 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.
CUSTOMER SUBMITTED THIS COMPLAINT ON 11/17/2023 TO THE MANUFACTURER. THEREFORE, THE AWARE DATE FOR THIS COMPLAINT IS 11/17/2023. AS A RESULT OF TECHNICAL PROBLEM IN ZENDESK THE CUSTOMER SUPPORT TEAM ENTERED THE COMPLAINT ON 11/23/2023 AND THIS DATE IS CONSIDERED AS COMPLAINT DATE RECEIVED. AS PER CUSTOMER THE TEST CAME UP AS FLU B POSITIVE WITHIN 10 MINUTES. CUSTOMER ENDED UP RUNNING A RAPID ANTIGEN TEST THAT WAS SPECIFIC FOR SARS-COV-2, FLU A, FLU B, AND RSV. THAT WAS NEGATIVE AND THEN HE RAN ANOTHER ONE OF OUR TESTS AND THAT CAME BACK NEGATIVE FOR ALL THREE ANALYTES. BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N. DID NOT REPLY. MAY I HAVE YOUR LOT AND TEST KIT #? LOT #: K10A110912223M5. TEST KIT #: 3B9B2V0B. WAS THE TEST COMPLETED ON A FLAT SURFACE? Y/N. DID NOT REPLY. WAS THE SWAB ROTATED 5 TIMES IN EACH NOSTRIL? Y/N. DID NOT REPLY. WERE YOU 6 FEET FROM ANOTHER PERSON WHEN TAKING THE TEST? DID NOT REPLY WERE YOU EXPOSED TO COVID WITH IN THE PREVIOUS 24 HOURS OF TESTING? DID NOT REPLY WAS THE VIAL LIQUID PURPLE IN COLOR? Y/N DID NOT REPLY WAS THE TEST MOVED WHILE IT WAS RUNNING? Y/N DID NOT REPLY HOW SOON AFTER THE INITIAL POSITIVE TEST WAS A RETEST(S) COMPLETED? DID NOT REPLY WHAT TEST DID YOU USE TO CONFIRM THE FALSE POSITIVE? A RAPID ANTIGEN TEST THAT WAS SPECIFIC FOR SARS-COV-2, FLU A, FLU B, AND RSV, AND A SECOND 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 DNR IF YES, HOW IS THE PERSON TESTED DOING? IS THE PERSON TESTED UNDERGOING ANY TREATMENT? - DNR 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
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1772360 | LUCIRA CHECK-IT COVID-19 TEST | COVID 19 TEST KIT | QJR | PFIZER, INC. | K10A110912223M5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |