BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M RESP-4-PLEX AMPLIFICATION REAGENT KIT

    MDR report key: 15692261 · Received October 28, 2022

    Report

    Report Number
    3005248192-2022-00925
    Event Type
    Malfunction
    Date Received
    October 28, 2022
    Date of Event
    October 1, 2022
    Report Date
    December 8, 2022
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    QJR
    Removal / Correction Number
    3005248192-11/22/22-006R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. ADDITIONAL QUALITY CONTROL MITIGATIONS HAVE BEEN PUT IN PLACE TO PREVENT REOCCURRENCE. ALL SUBSEQUENT LOTS OF ALINITY M RESP-4-PLEX AMP KITS ARE NOT IMPACTED. URGENT FIELD SAFETY NOTICE / FIELD CORRECTION RECALL (FA-AM-NOV2022-283) WAS ISSUED ON NOVEMBER 22, 2022 TO ADDRESS THIS ISSUE. THIS ACTION WAS COMMUNICATED TO THE FDA ON NOVEMBER 22, 2022 (3005248192-11/22/22-006-R). 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. 3005248192-2022-00904 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.

    Additional Manufacturer Narrative · 0

    ELEVATED COMPLAINT INVESTIGATION WILL BE INITIATED. 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. THE FOLLOWING MDRS ARE BEING SUBMITTED IN ASSOCIATION WITH THIS OBSERVATION: 3005248192-2022-00920, 3005248192-2022-00921, 3005248192-2022-00922, 3005248192-2022-00923, 3005248192-2022-00924, 3005248192-2022-00926, 3005248192-2022-00927, 3005248192-2022-00928, 3005248192-2022-00929, 3005248192-2022-00930, 3005248192-2022-00931.

    Description of Event or Problem · 0

    THE CUSTOMER QUESTIONED ALINITY M RESP-4-PLEX RESULTS FOR ALL PATIENT SPECIMENS RUN AFTER (B)(6) 2022. THE CUSTOMER NOTED A HIGH INCIDENCE OF FALSE RSV POSITIVE RESULTS ON ALINITY M SN (B)(4) WHEN USING THE RESP-4-PLEX ASSAY AND CONSIDERED ALL RESULTS GENERATED WITH A CN >36 TO BE ACTUALLY NEGATIVE AS NONE OF THE PATIENTS HAD SHOWN CLINICAL HISTORIES COMPATIBLE WITH RSV IN THE OPINION OF THE CLINICIANS. EVALUATION OF CUSTOMER LOG FILES BY ABBOTT PERSONNEL IDENTIFIED THAT OF THE SAMPLES PROCESSED BETWEEN (B)(6) 2022 TO (B)(6) 2022, 28 MEET THE CUSTOMERS CRITERIA FOR FALSE POSITIVE RESULTS (CN>36); ABBOTT PERSONNEL NOTED THAT CN VALUES WERE BETWEEN 36.76 AND 41.70. THE FOLLOWING PATIENT RESULTS WERE IDENTIFIED IN THIS REVIEW: RUN DATE (B)(6) 2022 WITH REAGENT LOT: 527602, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 38.17 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 527602, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 36.76 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 527602, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 37.73 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 527602, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 34.89 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 527602, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 38.35 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 531612, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 39.48 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 531612, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 38.95 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 531612, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 37.56 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 531612, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 40.19 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 531612, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 40.95 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 531612, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 37.49 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 531612, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 38.86 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 531612, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 38.16 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 531612, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 39.22 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 531612, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 41.70 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 531612, SID: (B)(6)ASSAY INTERPRETATION POSITIVE WITH 40.25 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 531612, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 39.39 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 531612, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 39.10 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 531612, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 38.53 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 531612, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 39.17 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 531612, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 37.69 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 531612, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 39.36 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 531612, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 39.62 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 531612, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 39.20 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 531612, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 39.12 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 531612, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 38.21 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 531612, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 41.52 CN, RUN DATE (B)(6) 2022 WITH REAGENT LOT: 531612, SID: (B)(6) ASSAY INTERPRETATION POSITIVE WITH 39.87 CN. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED OUTSIDE THE US 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. THE ADDITIONAL RUN DATES ASSOCIATED WITH THE ABOVE SIDS WILL BE REPORTED UNDER THE FOLLOWING MDRS: 3005248192-2022-00920 (RUN DATE (B)(6) 2022)), 3005248192-2022-00921 (RUN DATE (B)(6) 2022)), 3005248192-2022-00922 (RUN DATE (B)(6) 2022)), 3005248192-2022-00923 (RUN DATE (B)(6) 2022)), 3005248192-2022-00924 (RUN DATE (B)(6) 2022)), 3005248192-2022-00926 (RUN DATE (B)(6) 2022)), 3005248192-2022-00927 (RUN DATE (B)(6) 2022)), 3005248192-2022-00928 (RUN DATE (B)(6) 2022)), 3005248192-2022-00929 (RUN DATE (B)(6) 2022)), 3005248192-2022-00930 (RUN DATE (B)(6) 2022)), 3005248192-2022-00931 (RUN DATE (B)(6) 2022)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2692493 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