ALINITY M RESP-4-PLEX AMPLIFICATION REAGENT KIT
Report
- Report Number
- 3005248192-2022-01083
- Event Type
- Malfunction
- Date Received
- December 1, 2022
- Date of Event
- October 24, 2022
- Report Date
- January 24, 2023
- Manufacturer
- ABBOTT MOLECULAR, INC.
- Product Code
- QJR
- Removal / Correction Number
- 3005248192-11/22/22-006R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ELEVATED COMPLAINT INVESTIGATION WILL BE INITIATED. NOTE: LOT, EXPIRATION, UDI, MANUFACTURE DATE AND PMA NUMBER HAVE BEEN LEFT BLANK AS THIS MDR IS BEING SUBMITTED ON THE BASIS THAT ALINTY M RESP-4-PLEX AMPLIFICATION REAGENT KIT (LIST 9N79-90) IS SIMILAR TO THE ALINITY M RESP-4-PLEX AMPLIFICATION REAGENT KIT (LIST 9N79-96) SOLD IN THE UNITED STATES. TICKET DOES NOT REFERENCE A US LIST 9N79-96 LOT NUMBER.
INVESTIGATION INTO THIS COMPLAINT INCLUDED A CUSTOMER DATA REVIEW, A QUALITY DATA REVIEW, AND A COMPLAINT HISTORY REVIEW FOR THE DISCREPANT RESULTS INVOLVING THE NON-RSV AND NON-FLU B TARGETS. CUSTOMER RESULT LOG FILES WERE REVIEWED. THE VALIDITY OF THE RUNS MET ASSAY SPECIFICATION REQUIREMENTS, AND NO ERROR CODES OR FLAGS WERE DISPLAYED FOR THE RUN CONTROLS. THE DEVICE HISTORY RECORDS (DHR) REVIEW, CAPA REVIEW, AND COMPLAINT HISTORY REVIEW WAS PERFORMED. NO ISSUES WERE FOUND DURING QUALITY CONTROL (QC) TESTING. THE PRODUCTS PASSED QUALITY SPECIFICATIONS AT THE TIME OF RELEASE. THIS DHR , CAPA, AND COMPLAINT REVIEW DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-090) LOT 531612 FOR THE NON-RSV AND NON-FLU B TARGETS. BASED ON THE RESULTS OF THE INVESTIGATION, THE PRODUCT REQUIREMENTS CONTINUE TO BE MET FOR THIS LOT FOR THE FLU A TARGET OF THE ALINITY M RESP-4-PLEX ASSAY. THE ELEVATED COMPLAINT INVESTIGATION CONFIRMED THAT THIS COMPLAINT IS THE SAME EVENT IDENTIFIED IN A NONCONFORMANCE FOR AN INCREASE IN WEAK/LATE RSV AND/OR FLU B POSITIVES OBSERVED ON SPECIFIC LOTS OF THE ALINITY M RESP-4-PLEX ASSAY (LIST 09N79-090 AND 09N79-096) RESULTING IN FALSE POSITIVE AND NEGATIVE CONTROL REACTIVE SAMPLES. TECHNICAL PRODUCT SUPPORT TESTING INDICATES THERE HAS BEEN AN INCREASE IN FALSE POSITIVE RATE FOR THE FLU B AND RSV TARGETS, WITH SEVERAL LOTS EXCEEDING THE PRODUCT REQUIREMENT OF "FOR THE NEGATIVE PANEL MEMBERS, 98% OR GREATER OF REPLICATES SHALL REPORT A NEGATIVE RESULT FOR FLU A, FLU B, RSV, AND SARS-COV-2 (NEGATIVE RATE GREATER THAN OR EQUAL TO 98%)" PER ALINITY M RESP-4-PLEX ASSAY PRODUCT REQUIREMENTS FOR RSV AND FLU B. THIS STUDY ALSO DEMONSTRATES NO SIGNIFICANT IMPACT TO SARS-COV-2 OR FLU A TARGETS. FOR THESE SPECIFIC LOTS OF ALINITY M RESP-4-PLEX ASSAY (LIST 09N79-090 AND 09N79-096), A PRODUCT DEFICIENCY WAS IDENTIFIED. THE FOLLOWING MDRS WERE ALSO REPORTED AS RELATED TO FA-AM-NOV2022-283: 3005248192-2022-00709 FOLLOW UP REPORT 1, 3005248192-2022-00744 FOLLOW UP REPORT 1, 3005248192-2022-00765 FOLLOW UP REPORT 1, 3005248192-2022-00796 FOLLOW UP REPORT 1, 3005248192-2022-01095, 3005248192-2022-01096, 3005248192-2022-01097, 3005248192-2022-01098, 3005248192-2022-01099, 3005248192-2022-01100, 3005248192-2022-01101, 3005248192-2022-01102, 3005248192-2022-01103, 3005248192-2022-01104, 3005248192-2022-00716 FOLLOW UP 01, 3005248192-2022-00791 FOLLOW UP 01, 3005248192-2022-00735 FOLLOW UP 01, 3005248192-2022-00705 FOLLOW UP 01, 3005248192-2022-01123, 3005248192-2022-01124, 3005248192-2022-01125, 3005248192-2022-00752 FOLLOW UP 01, 3005248192-2022-00753 FOLLOW UP 01, 3005248192-2022-00743 FOLLOW UP 01, 3005248192-2022-00719 FOLLOW UP 01, 3005248192-2022-00978 FOLLOW UP 01, 3005248192-2022-00979 FOLLOW UP 01, 3005248192-2022-00980 FOLLOW UP 01, 3005248192-2022-00937 FOLLOW UP 01, 3005248192-2022-01017 FOLLOW UP 01, 3005248192-2022-01018 FOLLOW UP 01, 3005248192-2022-01148, 3005248192-2022-00934 FOLLOW UP REPORT 1, 3005248192-2022-00942 FOLLOW UP REPORT 1, 3005248192-2022-00943 FOLLOW UP REPORT 1, 3005248192-2022-00944 FOLLOW UP REPORT 1, 3005248192-2022-00945 FOLLOW UP REPORT 1, 3005248192-2022-00946 FOLLOW UP REPORT 1, 3005248192-2022-00920 FOLLOW UP REPORT 1, 3005248192-2022-00921 FOLLOW UP REPORT 1, 3005248192-2022-00922 FOLLOW UP REPORT 1, 3005248192-2022-00923 FOLLOW UP REPORT 1, 3005248192-2022-00924 FOLLOW UP REPORT 1, 3005248192-2022-00925 FOLLOW UP REPORT 1, 3005248192-2022-00926 FOLLOW UP REPORT 1, 3005248192-2022-00927 FOLLOW UP REPORT 1, 3005248192-2022-00928 FOLLOW UP REPORT 1, 3005248192-2022-00929 FOLLOW UP REPORT 1, 3005248192-2022-00930 FOLLOW UP REPORT 1, 3005248192-2022-00931 FOLLOW UP REPORT 1, 3005248192-2022-01198, 3005248192-2022-01199, 3005248192-2022-01200, 3005248192-2022-00707 FOLLOW UP REPORT 1, 3005248192-2022-00757 FOLLOW UP REPORT 1, 3005248192-2022-00718 FOLLOW UP REPORT 1, 3005248192-2022-00964 FOLLOW UP REPORT 1, 3005248192-2022-00965 FOLLOW UP REPORT 1, 3005248192-2022-00966 FOLLOW UP REPORT 1, 3005248192-2022-00967 FOLLOW UP REPORT 1, 3005248192-2022-00968 FOLLOW UP REPORT 1, 3005248192-2022-00969 FOLLOW UP REPORT 1, 3005248192-2022-00970 FOLLOW UP REPORT 1, 3005248192-2022-00971 FOLLOW UP REPORT 1, 3005248192-2022-00798 FOLLOW UP 01, 3005248192-2022-01206, 3005248192-2022-00800 FOLLOW UP REPORT 1, 3005248192-2022-00801 FOLLOW UP REPORT 1, 3005248192-2022-00742 FOLLOW UP REPORT 1, 3005248192-2022-00883 FOLLOW UP REPORT 1, 3005248192-2022-00884 FOLLOW UP REPORT 1, 3005248192-2022-00885 FOLLOW UP REPORT 1, 3005248192-2022-00886 FOLLOW UP REPORT 1, 3005248192-2022-00887 FOLLOW UP REPORT 1, 3005248192-2022-00888 FOLLOW UP REPORT 1, 3005248192-2022-00889 FOLLOW UP REPORT 1, 3005248192-2022-00890 FOLLOW UP REPORT 1, 3005248192-2022-00891 FOLLOW UP REPORT 1, 3005248192-2022-00892 FOLLOW UP REPORT 1, 3005248192-2022-00893 FOLLOW UP REPORT 1, 3005248192-2022-00894 FOLLOW UP REPORT 1, 3005248192-2022-00895 FOLLOW UP REPORT 1, 3005248192-2022-01207, 3005248192-2022-01223, 3005248192-2022-00899 FOLLOW UP REPORT 1, 3005248192-2022-01239, 3005248192-2022-01241, 3005248192-2022-00878 FOLLOW UP 01, 3005248192-2022-00879 FOLLOW UP 01, 3005248192-2022-00880 FOLLOW UP 01, 3005248192-2022-00881 FOLLOW UP 01, 3005248192-2022-00882 FOLLOW UP 01, 3005248192-2022-00907 FOLLOW UP 01, 3005248192-2022-00908 FOLLOW UP 01, 3005248192-2022-00909 FOLLOW UP 01, 3005248192-2022-00910 FOLLOW UP 01, 3005248192-2022-00911 FOLLOW UP 01, 3005248192-2022-00794 FOLLOW UP 03, 3005248192-2022-00804 FOLLOW UP 01, 3005248192-2022-00912 FOLLOW UP 01, 3005248192-2022-00913 FOLLOW UP 01, 3005248192-2022-00810 FOLLOW UP 03, 3005248192-2022-00811 FOLLOW UP 02, 3005248192-2022-00812 FOLLOW UP 02, 3005248192-2022-00813 FOLLOW UP 01, 3005248192-2022-00816 FOLLOW UP 01, 3005248192-2022-00817 FOLLOW UP 01, 3005248192-2022-00818 FOLLOW UP 01, 3005248192-2023-00002, 3005248192-2023-00005, 3005248192-2022-00823 FOLLOW UP 01, 3005248192-2022-00824 FOLLOW UP 01, 3005248192-2022-00825 FOLLOW UP 01, 3005248192-2022-00826 FOLLOW UP 01, 3005248192-2022-00827 FOLLOW UP 01, 3005248192-2022-00828 FOLLOW UP 01, 3005248192-2022-00830 FOLLOW UP 01, 3005248192-2022-00831 FOLLOW UP 01, 3005248192-2022-00833 FOLLOW UP 01, 3005248192-2022-01022 FOLLOW UP 01, 3005248192-2022-01023 FOLLOW UP 01, 3005248192-2022-01024 FOLLOW UP 01, 3005248192-2022-00835 FOLLOW UP 01, 3005248192-2022-01025 FOLLOW UP 01, 3005248192-2022-01026 FOLLOW UP 01, 3005248192-2022-01027 FOLLOW UP 01, 3005248192-2022-00837 FOLLOW UP 01, 3005248192-2022-00839 FOLLOW UP 01, 3005248192-2022-00840 FOLLOW UP 01, 3005248192-2022-00842 FOLLOW UP 01, 3005248192-2022-00843 FOLLOW UP 01, 3005248192-2023-00006, 3005248192-2022-00844 FOLLOW UP 01, 3005248192-2023-00007, 3005248192-2022-00846 FOLLOW UP 01, 3005248192-2022-00847 FOLLOW UP 01, 3005248192-2022-00848 FOLLOW UP 01, 3005248192-2022-00849 FOLLOW UP 01, 3005248192-2022-00851 FOLLOW UP 01, 3005248192-2022-00852 FOLLOW UP 01, 3005248192-2022-00853 FOLLOW UP 01, 3005248192-2022-00855 FOLLOW UP 01, 3005248192-2022-00856 FOLLOW UP 01, 3005248192-2022-00862 FOLLOW UP 01, 3005248192-2022-00866 FOLLOW UP 01, 3005248192-2022-00869 FOLLOW UP 01, 3005248192-2022-00870 FOLLOW UP 01, 3005248192-2022-00875 FOLLOW UP 01, 3005248192-2022-00877 FOLLOW UP 01, 3005248192-2022-01108 FOLLOW UP 01, 3005248192-2022-01119 FOLLOW UP 01, 3005248192-2022-01120 FOLLOW UP 01, 3005248192-2022-01121 FOLLOW UP 01, 3005248192-2022-01122 FOLLOW UP 01, 3005248192-2022-00983 FOLLOW UP REPORT 1, 3005248192-2022-00955 FOLLOW UP REPORT 1, 3005248192-2022-01111 FOLLOW UP 01, 3005248192-2022-01112 FOLLOW UP 01, 3005248192-2022-01113 FOLLOW UP 01, 3005248192-2022-01114 FOLLOW UP 01, 3005248192-2022-01064 FOLLOW UP 01, 3005248192-2022-01065 FOLLOW UP 01, 3005248192-2022-01066 FOLLOW UP 01, 3005248192-2022-01030 FOLLOW UP 01, 3005248192-2022-01031 FOLLOW UP 01, 3005248192-2022-01032 FOLLOW UP 01, 3005248192-2022-01033 FOLLOW UP 01, 3005248192-2022-01034 FOLLOW UP 01, 3005248192-2022-01035 FOLLOW UP 01, 3005248192-2022-01036 FOLLOW UP 01, 3005248192-2023-00014, 3005248192-2023-00015, 3005248192-2022-01019 FOLLOW UP 01, 3005248192-2022-01028 FOLLOW UP 01, 3005248192-2022-01115 FOLLOW UP 01, 3005248192-2022-01116 FOLLOW UP 01, 3005248192-2022-01117 FOLLOW UP 01, 3005248192-2022-01118 FOLLOW UP 01, 3005248192-2022-01128 FOLLOW UP 01, 3005248192-2022-01129 FOLLOW UP 01, 3005248192-2022-01139 FOLLOW UP 01, 3005248192-2022-01140 FOLLOW UP 01, 3005248192-2022-01141 FOLLOW UP 01, 3005248192-2022-01143 FOLLOW UP 01, 3005248192-2022-01144 FOLLOW UP 01, 3005248192-2022-01145 FOLLOW UP 01, 3005248192-2022-01146 FOLLOW UP 01, 3005248192-2022-01147 FOLLOW UP 01, 3005248192-2022-01057 FOLLOW UP 01, 3005248192-2022-01058 FOLLOW UP 01, 3005248192-2022-01059 FOLLOW UP 01, 3005248192-2022-01060 FOLLOW UP 01, 3005248192-2022-01061 FOLLOW UP 01, 3005248192-2022-01062 FOLLOW UP 01, 3005248192-2022-01079 FOLLOW UP 01, 3005248192-2022-01080 FOLLOW UP 01, 3005248192-2022-01081 FOLLOW UP 01, 3005248192-2022-01082 FOLLOW UP 01, 3005248192-2022-01083 FOLLOW UP 01, 3005248192-2022-01084 FOLLOW UP 01.
THE CUSTOMER QUESTIONED ALINITY M RESP-4-PLEX RESULTS WITH THE FLU B AND RSV TARGETS. THE CUSTOMER NOTED THAT THE QUESTIONED FLU B SAMPLES RESULTED WITH A CT GREATER THAN 37 AND RETESTING OF THE SAMPLES WITH A SEEGENE AND/OR A PANTHER ASSAY ALWAYS PROVIDED NEGATIVE RESULTS. THE CUSTOMER HAS NOT SPECIFIED WHICH RESULTS WERE RETESTED WITH ANOTHER METHOD OR HOW MANY SAMPLES HAVE BEEN RETESTED. THE CUSTOMER QUESTIONED RSV SAMPLES WITH CT VALUES BETWEEN 36.38 AND 41.87 THAT COULD NOT BE CONFIRMED WITH THE SEEGENE ALLPLEX RV. SOME SAMPLES WERE NOTED TO BE FROM A POOL TESTING FROM A LOCAL KINDERGARDEN, THE FOLLOWING INFORMATION WAS OBTAINED FROM THE CUSTOMER'S RUN DATA BASED ON THE SIDS PROVIDED: SID 1142665366 RUN DATE 10/17/2022 WITH REAGENT LOT 531612 INTERPRETATION FLU B POSITIVE ( 38.13 CN ) AND RSV POSITIVE ( 40.27 CN); ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE FLU B RESULT. SID 1142707766 RUN DATE 10/17/2022 WITH REAGENT LOT 531612 INTERPRETATION FLU B POSITIVE ( 36.19 CN ) AND RSV POSITIVE ( 37.49 CN ); ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE FLU B RESULT. SID 1142716466 RUN DATE 10/17/2022 WITH REAGENT LOT 531612 INTERPRETATION FLU B POSITIVE ( 36.09 CN ) AND RSV POSITIVE ( 40.89 CN ); ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE FLU B RESULT. SID 4617562266 RUN DATE 10/17/2022 WITH REAGENT LOT 531612 INTERPRETATION RSV POSITIVE ( 36.23 CN ), FLU B POSITIVE ( 37.10 CN ); ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE FLU B RESULT. SID 4617562366 RUN DATE 10/17/2022 WITH REAGENT LOT 531612 INTERPRETATION FLU B POSITIVE ( 37.31 CN ) AND RSV POSITIVE ( 36.47 CN ); ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE FLU B RESULT. SID 4617562566 RUN DATE 10/17/2022 WITH REAGENT LOT 531612 INTERPRETATION RSV POSITIVE ( 37.13 CN ), FLU B POSITIVE ( 36.89 CN ) AND SARS-COV-2 POSITIVE ( 36.61 CN ); FLU A WAS NOT DETECTED. THE CUSTOMER QUESTIONS THE FLU B RESULT. SID 4617563366 RUN DATE 10/17/2022 WITH REAGENT LOT 531612 INTERPRETATION FLU B POSITIVE ( 37.38 CN ); ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE FLU B RESULT. SID 4617623466 RUN DATE 10/17/2022 WITH REAGENT LOT 531612 INTERPRETATION RSV POSITIVE ( 37.31 CN ), FLU B POSITIVE ( 35.67 CN ); ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE FLU B RESULT. SID 4617624466 RUN DATE 10/17/2022 WITH REAGENT LOT 531612 INTERPRETATION FLU B POSITIVE ( 35.67 CN ); ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE FLU B RESULT. SID 8045568366 RUN DATE 10/17/2022 WITH REAGENT LOT 531612 INTERPRETATION RSV POSITIVE ( 40.78 CN ), FLU B POSITIVE ( 37.71 CN ); ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE FLU B RESULT. SID 1142780766 RUN DATE 10/18/2022 WITH REAGENT LOT 531612 INTERPRETATION RSV POSITIVE ( 40.03 CN ); ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE RSV RESULT. SID 3057508366 RUN DATE 10/18/2022 WITH REAGENT LOT 531612 INTERPRETATION RSV POSITIVE ( 41.87 CN ); ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE RSV RESULT. SID 4616889566 RUN DATE 10/18/2022 WITH REAGENT LOT 531612 INTERPRETATION RSV POSITIVE ( 41.17 CN ); ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE RSV RESULT. SID 4617459766 RUN DATE 10/18/2022 WITH REAGENT LOT 531612 INTERPRETATION RSV POSITIVE ( 38.49 CN ); ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE RSV RESULT. SID 4617461266 RUN DATE 10/18/2022 WITH REAGENT LOT 531612 INTERPRETATION RSV POSITIVE ( 39.50 CN ); ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE RSV RESULT. SID 4617114666 RUN DATE 10/18/2022 WITH REAGENT LOT 531612 INTERPRETATION FLU B POSITIVE ( 38.74 CN ); ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE FLU B RESULT. SID 4617459966 RUN DATE 10/18/2022 WITH REAGENT LOT 531612 INTERPRETATION FLU B POSITIVE ( 37.47 CN ) ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE FLU B RESULT. SID 4617460066 RUN DATE 10/18/2022 WITH REAGENT LOT 531612 INTERPRETATION FLU B POSITIVE ( 38.29 CN ) AND RSV POSITIVE ( 41.03 CN ); ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE FLU B RESULT. SID 4617462066 RUN DATE 10/18/2022 WITH REAGENT LOT 531612 INTERPRETATION FLU B POSITIVE ( 37.27 CN ); ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE FLU B RESULT. SID 7213228066 RUN DATE 10/19/2022 WITH REAGENT LOT 531612 INTERPRETATION RSV POSITIVE ( 40.31 CN ); ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE RSV RESULT. SID 8045574866 RUN DATE 10/19/2022 WITH REAGENT LOT 531612 INTERPRETATION RSV POSITIVE ( 41.72 CN ); ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE RSV RESULT. SID 1142923866 RUN DATE 10/20/2022 WITH REAGENT LOT 531612 INTERPRETATION FLU B POSITIVE ( 37.38 CN ) ; ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE FLU B RESULT. SID 4617869266 RUN DATE 10/20/2022 WITH REAGENT LOT 531612 INTERPRETATION FLU B POSITIVE ( 37.35 CN ); ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE FLU B RESULT. SID 7213225366 RUN DATE 10/20/2022 WITH REAGENT LOT 531612 INTERPRETATION FLU B POSITIVE ( 38.84 CN ), RSV POSITIVE ( 38.44 CN ); ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE FLU B RESULT. SID 7213225466 RUN DATE 10/20/2022 WITH REAGENT LOT 531612 INTERPRETATION FLU B POSITIVE ( 38.40 CN ), RSV POSITIVE ( 38.80 CN ); ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE FLU B RESULT. SID 7213333166 RUN DATE 10/24/2022 WITH REAGENT LOT 531612 INTERPRETATION FLU B POSITIVE ( 37.07 CN); ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE FLU B RESULT. SID 4617717166 RUN DATE 10/24/2022 WITH REAGENT LOT 531612 INTERPRETATION FLU B POSITIVE ( 35.96 CN ) AND RSV POSITIVE ( 39.24 CN ); ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE FLU B RESULT. SID 7213455766 RUN DATE 10/25/2022 WITH REAGENT LOT 531612 INTERPRETATION FLU B POSITIVE ( 39.08 CN ), RSV POSITIVE ( 40.34 CN ); ALL OTHER TARGETS NOT DETECTED; THE CUSTOMER QUESTIONS THE FLU B RESULT. IT IS UNCLEAR WHAT RESULT THE CUSTOMER BELIEVES TO BE THE CORRECT RESULT FOR THESE PATIENTS, THEREFORE THIS REPORT WILL BE SUBMITTED ASSUMING THE CUSTOMER BELIEVES THESE RESULTS TO BE FALSELY POSITIVE. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN (B)(6) USING THE ALINITY M RESP-4-PLEX ASSAY, LIST NUMBER 9N79-90, WHICH IS THE SAME/SIMILAR TO THE ALINITY M RESP-4-PLEX ASSAY, LIST NUMBER 9N79-96, WHICH RECEIVED FDA EUA APPROVAL. AS THE CUSTOMER EXPERIENCED QUESTIONED RUNS ON MULTIPLE DATES, THE FOLLOWING REPORTS WILL BE SUBMITTED DESCRIBING THE SAME EVENT WITH THE CORRESPONDING DATES OF EVENT: 3005248192-2022-01079 RUN DATE 10/17, 3005248192-2022-01080 RUN DATE 10/18, 3005248192-2022-01081 RUN DATE 10/19, 3005248192-2022-01082 RUN DATE 10/20, 3005248192-2022-01083 RUN DATE 10/24, 3005248192-2022-01084 RUN DATE 10/25.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2607475 | ALINITY M RESP-4-PLEX AMPLIFICATION REAGENT KIT | REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | QJR | ABBOTT MOLECULAR, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |