BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M RESP-4-PLEX AMPLIFICATION REAGENT KIT

    MDR report key: 15503158 · Received September 29, 2022

    Report

    Report Number
    3005248192-2022-00891
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    August 28, 2022
    Report Date
    December 13, 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
    PHYSICIAN
    Health Professional
    Yes

    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.

    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: 3005248192-2022-00883; 3005248192-2022-00884; 3005248192-2022-00885; 3005248192-2022-00886; 3005248192-2022-00887; 3005248192-2022-00888; 3005248192-2022-00889; 3005248192-2022-00890; 3005248192-2022-00892; 3005248192-2022-00893; 3005248192-2022-00894; 3005248192-2022-00895.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 3 FALSE POSITIVE RESULTS ON SAMPLE IDS (SID) (B)(6) FOR RSV WHILE USING THE ALINITY M RESP-4-PLEX ASSAY. THE CUSTOMER DID NOT BELIEVE THE POSITIVE RESULTS AND THE SAMPLES WERE REPORTED AS NEGATIVE. THE FALSE POSITIVE RESULTS WERE NOT RELEASED FROM THE LABORATORY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN SPAIN 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2934936 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