BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M RESP-4-PLEX AMPLIFICATION REAGENT KIT

    MDR report key: 15634808 · Received October 19, 2022

    Report

    Report Number
    3005248192-2022-00911
    Event Type
    Malfunction
    Date Received
    October 19, 2022
    Date of Event
    October 5, 2022
    Report Date
    December 21, 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
    FR
    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, 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.

    Additional Manufacturer Narrative · 0

    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. THE FOLLOWING MDRS ARE BEING SUBMITTED IN ASSOCIATION WITH THIS OBSERVATION: 3005248192-2022-00907, 3005248192-2022-00908, 3005248192-2022-00909, 3005248192-2022-00910.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 6 FALSE POSITIVE RESULTS FOR THE RSV TARGET ON THE ALINITY M RESP-4-PLEX ASSAY. THE CUSTOMER REPORTED THE FOLLOWING FALSE POSITIVE SAMPLE IDS (SIDS) AND ASSOCIATE DATE OF RUN: SIDS: (B)(6). NO IMPACT ON PATIENT MANAGEMENT REPORTED. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN FRANCE 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: 3005248192-2022-00907, 3005248192-2022-00908, 3005248192-2022-00909, AND 3005248192-2022-00910.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2939112 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