BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M RESP-4-PLEX AMPLIFICATION REAGENT KIT

    MDR report key: 15947131 · Received December 8, 2022

    Report

    Report Number
    3005248192-2022-01147
    Event Type
    Malfunction
    Date Received
    December 8, 2022
    Date of Event
    November 18, 2022
    Report Date
    February 22, 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
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ELEVATED COMPLAINT INVESTIGATION WILL BE INITIATED.

    Additional Manufacturer Narrative · 0

    CORRECTION: PREVIOUS FOLLOW-UP REPORTS 01 AND 02 INADVERTENTLY SENT IN ERROR; DATA WAS INTENDED TO BE FOR ANOTHER SIMILAR REPORT (3005248192-2022-01047) FOR A SIMILAR ISSUE, HOWEVER A TYPOGRAPHICAL ERROR WAS MADE IN THE SUBMISSION NUMBER.. INVESTIGATION INTO THIS COMPLAINT INCLUDED A CUSTOMER DATA REVIEW, A QUALITY DATA REVIEW, AND A COMPLAINT HISTORY REVIEW FOR THE DISCREPANT RESULTS INVOLVING ALINITY M RESP-4-PLEX AMPLIFICATION KIT REAGENT LIST NUMBER 09N79-090 LOT 382437. 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 AMPLIFICATION KIT REAGENT LIST NUMBER 09N79-090 LOT 382437. BASED ON THE RESULTS OF THE INVESTIGATION, THE PRODUCT REQUIREMENTS CONTINUE TO BE MET FOR THIS LOT. 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) INCLUDING LOT 531612 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 3005248192-2022-01086 FOLLOW UP 01 3005248192-2022-01087 FOLLOW UP 01 3005248192-2022-01251 FOLLOW UP 01 3005248192-2022-01201 FOLLOW UP 01 3005248192-2022-01202 FOLLOW UP 01 3005248192-2022-01203 FOLLOW UP 01 3005248192-2022-01204 FOLLOW UP 01 3005248192-2022-01205 FOLLOW UP 01 3005248192-2022-01252 FOLLOW UP 01 3005248192-2022-01253 FOLLOW UP 01 3005248192-2022-01054 FOLLOW UP 01 3005248192-2022-01209 FOLLOW UP 01 3005248192-2022-01210 FOLLOW UP 01 3005248192-2022-01211 FOLLOW UP 01 3005248192-2022-01212 FOLLOW UP 01 3005248192-2022-01213 FOLLOW UP 01 3005248192-2022-01214 FOLLOW UP 01 3005248192-2022-01215 FOLLOW UP 01 3005248192-2022-01216 FOLLOW UP 01 3005248192-2022-01217 FOLLOW UP 01 3005248192-2022-01218 FOLLOW UP 01 3005248192-2022-01219 FOLLOW UP 01 3005248192-2022-01037 FOLLOW UP 01 3005248192-2022-01038 FOLLOW UP 01 3005248192-2022-01039 FOLLOW UP 01 3005248192-2022-01040 FOLLOW UP 01 3005248192-2022-01041 FOLLOW UP 01 3005248192-2023-00082 3005248192-2022-01152 FOLLOW UP REPORT 1 3005248192-2022-01153 FOLLOW UP REPORT 1 3005248192-2022-01154 FOLLOW UP REPORT 1 3005248192-2022-01155 FOLLOW UP REPORT 1 3005248192-2022-01156 FOLLOW UP REPORT 1 3005248192-2022-01157 FOLLOW UP REPORT 1 3005248192-2022-01158 FOLLOW UP REPORT 1 3005248192-2022-01159 FOLLOW UP REPORT 1 3005248192-2022-01160 FOLLOW UP REPORT 1 3005248192-2022-01161 FOLLOW UP REPORT 1 3005248192-2022-01162 FOLLOW UP REPORT 1 3005248192-2022-01163 FOLLOW UP REPORT 1 3005248192-2022-01164 FOLLOW UP REPORT 1 3005248192-2022-01165 FOLLOW UP REPORT 1 3005248192-2022-01166 FOLLOW UP REPORT 1 3005248192-2022-01167 FOLLOW UP REPORT 1 3005248192-2022-01168 FOLLOW UP REPORT 1 3005248192-2022-01169 FOLLOW UP REPORT 1 3005248192-2022-01170 FOLLOW UP REPORT 1 3005248192-2022-01171 FOLLOW UP REPORT 1 3005248192-2022-01172 FOLLOW UP REPORT 1 3005248192-2022-01173 FOLLOW UP REPORT 1 3005248192-2022-01174 FOLLOW UP REPORT 1 3005248192-2022-01175 FOLLOW UP REPORT 1 3005248192-2022-01176 FOLLOW UP REPORT 1 3005248192-2022-01177 FOLLOW UP REPORT 1 3005248192-2022-01178 FOLLOW UP REPORT 1 3005248192-2022-01179 FOLLOW UP REPORT 1 3005248192-2022-01180 FOLLOW UP REPORT 1 3005248192-2022-01181 FOLLOW UP REPORT 1 3005248192-2022-00984 FOLLOW UP 01 3005248192-2022-00985 FOLLOW UP 01 3005248192-2022-00986 FOLLOW UP 01 3005248192-2022-00987 FOLLOW UP 01 3005248192-2022-00988 FOLLOW UP 01 3005248192-2022-00989 FOLLOW UP 01 3005248192-2022-00990 FOLLOW UP 01 3005248192-2022-00991 FOLLOW UP 01 3005248192-2022-00992 FOLLOW UP 01 3005248192-2022-00993 FOLLOW UP 01 3005248192-2022-00994 FOLLOW UP 01 3005248192-2022-00995 FOLLOW UP 01 3005248192-2022-00996 FOLLOW UP 01 3005248192-2022-00997 FOLLOW UP 01 3005248192-2022-00998 FOLLOW UP 01 3005248192-2022-00999 FOLLOW UP 01 3005248192-2022-01000 FOLLOW UP 01 3005248192-2022-01001 FOLLOW UP 01 3005248192-2022-01002 FOLLOW UP 01 3005248192-2022-01003 FOLLOW UP 01 3005248192-2022-01004 FOLLOW UP 01 3005248192-2022-01005 FOLLOW UP 01 3005248192-2022-01006 FOLLOW UP 01 3005248192-2022-01007 FOLLOW UP 01 3005248192-2022-01008 FOLLOW UP 01 3005248192-2022-01009 FOLLOW UP 01 3005248192-2022-01010 FOLLOW UP 01 3005248192-2022-01011 FOLLOW UP 01 3005248192-2022-01012 FOLLOW UP 01 3005248192-2022-01013 FOLLOW UP 01 3005248192-2022-01014 FOLLOW UP 01 3005248192-2022-01015 FOLLOW UP 01 3005248192-2022-01016 FOLLOW UP 01 3005248192-2022-01056 FOLLOW UP 01 3005248192-2022-01184 FOLLOW UP 01 3005248192-2022-01185 FOLLOW UP 01 3005248192-2022-01186 FOLLOW UP 01 3005248192-2022-01187 FOLLOW UP 01 3005248192-2022-01188 FOLLOW UP 01 3005248192-2022-01189 FOLLOW UP 01 3005248192-2022-01190 FOLLOW UP 01 3005248192-2022-01191 FOLLOW UP 01 3005248192-2022-01192 FOLLOW UP 01 3005248192-2022-01193 FOLLOW UP 01 3005248192-2022-01194 FOLLOW UP 01 3005248192-2022-01195 FOLLOW UP 01 3005248192-2022-01196 FOLLOW UP 01 3005248192-2022-01043 FOLLOW UP 01 3005248192-2022-01044 FOLLOW UP 01 3005248192-2022-01045 FOLLOW UP 01 3005248192-2022-01046 FOLLOW UP 01 3005248192-2022-01047 FOLLOW UP 01 3005248192-2022-01106 FOLLOW UP 01 3005248192-2022-01042 FOLLOW UP 01 3005248192-2023-00098 FOLLOW UP 01 3005248192-2022-01088 FOLLOW UP 01 3005248192-2022-01089 FOLLOW UP 01 3005248192-2022-01090 FOLLOW UP 01 3005248192-2022-01091 FOLLOW UP 01 3005248192-2022-01092 FOLLOW UP 01 3005248192-2022-01093 FOLLOW UP 01 3005248192-2022-01094 FOLLOW UP 01 3005248192-2022-01130 FOLLOW UP 01 3005248192-2022-01131 FOLLOW UP 01 3005248192-2022-01132 FOLLOW UP 01 3005248192-2022-01133 FOLLOW UP 01 3005248192-2022-01134 FOLLOW UP 01 3005248192-2022-01135 FOLLOW UP 01 3005248192-2022-01136 FOLLOW UP 01 3005248192-2022-01137 FOLLOW UP 01 3005248192-2022-01138 FOLLOW UP 01 3005248192-2022-01053 FOLLOW UP 01 3005248192-2022-01242 FOLLOW UP 01 3005248192-2022-01243 FOLLOW UP 01 3005248192-2022-01244 FOLLOW UP 01 3005248192-2022-01245 FOLLOW UP 01 3005248192-2022-01246 FOLLOW UP 01 3005248192-2022-01247 FOLLOW UP 01 3005248192-2022-01067 FOLLLOW UP 01 3005248192-2022-01068 FOLLLOW UP 01 3005248192-2022-01069 FOLLLOW UP 01 3005248192-2022-01070 FOLLLOW UP 01 3005248192-2022-01071 FOLLLOW UP 01 3005248192-2022-01072 FOLLLOW UP 01 3005248192-2022-01073 FOLLLOW UP 01 3005248192-2022-01074 FOLLLOW UP 01 3005248192-2022-01075 FOLLLOW UP 01 3005248192-2022-01076 FOLLLOW UP 01 3005248192-2022-01077 FOLLLOW UP 01 3005248192-2022-01078 FOLLLOW UP 01 3005248192-2022-01149 FOLLOW UP 01.

    Additional Manufacturer Narrative · 0

    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 (B)(4): 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 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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

    Additional Manufacturer Narrative · 0

    3005248192-2022-01147 FOLLOW UP 01 INCORRECTLY INDICATED THE DATE RECEIVED BY MANUFACTURER WAS 12/23/22; THE CORRECT DATE RECEIVED BY MANUFACTURER FOR FOLLOW UP REPORT 01 WAS 1/11/2023.

    Description of Event or Problem · 0

    THE CUSTOMER IDENTIFIED FALSE POSITIVE RESULTS FOR MULTIPLE PATIENTS WHEN USING THE ALINITY M RESP-4-PLEX ASSAY FOR THE FLU B AND RSV TARGETS. THE FOLLOWING SIDS AND RUN DATES WERE NOTED: SAMPLE ID: (B)(6) RUN DATE (B)(6) 2022 , AMP KIT LOT #531612, FLU B :38.29 CN, RSV: 41.25 CN, SAMPLE ID: (B)(6) RUN DATE (B)(6) 2022 , AMP KIT LOT #531612, RSV: 41.64 CN, SAMPLE ID: (B)(6) RUN DATE (B)(6) 2022 , AMP KIT LOT #531612, RSV: 41.11 CN, SAMPLE ID: (B)(6) RUN DATE (B)(6) 2022 , AMP KIT LOT #531612, FLU B: 31.86 CN, SAMPLE ID: (B)(6) RUN DATE (B)(6) 2022 , AMP KIT LOT #531612, FLU B: : 38.48 CN, SAMPLE ID: (B)(6) RUN DATE (B)(6) 2022 , AMP KIT LOT #531612, FLU B: : 38.61 CN, ALL SAMPLES WERE RERUN ON COMPETITOR PLATFORM AND VERIFIED AS NEGATIVE. ADDITIONAL SAMPLES WERE SUBESQURTLY REPORTED BY THE CUSTOMER AS BEING QUESTIONED AFTER THE CUSTOMER CHANGED REAGENT LOTS: SAMPLE ID: 803134 , RUN DATE 23.11.2022, AMP KIT LOT#382437, FLU A 37,94 CN; FLU B 35,41 ; SAMPLE ID: 803121 , RUN DATE 23.11.2022, AMP KIT LOT#382437, FLU B 29,59 CN; SAMPLE ID: 803199 , RUN DATE 23.11.2022, AMP KIT LOT#382437, FLU A 30,6, FLU B 34,91. ALL THREE SAMPLES TESTED NEGATIVE ON AUTOMATED INTEGRATED GENE DETECTION SYSTEM FROM FA. HANGZHOU LIFEREAL BIOTECHNOLOGY PLATFORM. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED INTERNATIONALLY 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 THIS EVENT OCCURRED ON MULTIPLE DATES, THIS EVENT WILL ADDITIONALLY BE SUBMITTED WITH THE FOLLOWING MDRS WITH THE ASSOCIATED DATE OF EVENT: 3005248192-2022-01143 DATE OF EVENT (B)(6) 2022 WITH LOT #531612, 3005248192-2022-01144 DATE OF EVENT (B)(6) 2022 WITH LOT #531612, 3005248192-2022-01145 DATE OF EVENT (B)(6) 2022 WITH LOT #531612, 3005248192-2022-01146 DATE OF EVENT (B)(6) 2022 WITH LOT #531612, 3005248192-2022-01147 DATE OF EVENT (B)(6) 2022 WITH LOT #531612, 3005248192-2022-01197 DATE OF EVENT (B)(6) 2022 WITH LOT #382437.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2916405 ALINITY M RESP-4-PLEX AMPLIFICATION REAGENT KIT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT MOLECULAR, INC. 531612

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown