BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M RESP-4-PLEX AMP KIT

    MDR report key: 21453273 · Received February 24, 2025

    Report

    Report Number
    3005248192-2025-00038
    Event Type
    Malfunction
    Date Received
    February 24, 2025
    Date of Event
    February 4, 2025
    Report Date
    June 5, 2025
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    QJR
    UDI-DI
    00884999049390
    PMA / PMN Number
    P190025
    Removal / Correction Number
    3005248192-04/28/25-002-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER INVESTIGATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM THE ALINITY M SYSTEM TO THE ALINITY M RESP-4-PLEX AMP KIT. THEREFORE, THE SUSPECT MEDICAL DEVICE INFORMATION WAS UPDATED. THE FOLLOWING UPDATES WERE MADE: SECTION D1: UPDATED BRAND NAME FROM ALINITY M SYSTEM TO ALINITY M RESP-4-PLEX AMP KIT. SECTION D2: UPDATED REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM, PRODUCT CODE: OOI TO REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID, PRODUCT CODE QJR. SECTION D4: UPDATED CATALOG # FROM 08N53-002 TO 09N79-096. SECTION D4: UPDATED SERIAL NUMBER FROM (B)(6) TO BLANK. SECTION D4: UPDATED LOT NUMBER FROM BLANK TO 409384. SECTION D4: UPDATED EXPIRATION DATE FROM BLANK TO 30-OCT-2025. SECTION D4: UPDATED PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) FROM (B)(4). SECTION G4: UPDATED PMA/510(K) FROM P190025 TO BLANK. SECTION H4: UPDATED DEVICE MANUFACTURE DATE FROM 11-JUN-2020 TO 12-NOV-2024.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS COMPLAINT INCLUDED A CUSTOMER DATA REVIEW AND A QUALITY DATA REVIEW. THE RESULTS OF THE INVESTIGATION ARE SUMMARIZED AS FOLLOWS: CUSTOMER DATA REVIEW: THE COMPLAINT TICKET REPORTED WEAK FALSE POSITIVE RESULTS WHILE USING ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-090) LOT 409383. CUSTOMER DATA REVIEW CONFIRMS THIS OBSERVATION. QUALITY DATA REVIEW: CAPA / NON-CONFORMANCE REVIEW: A CAPA REVIEW WAS PERFORMED TO IDENTIFY ANY RECORDS THAT WERE RELATED TO THE REPORTED COMPLAINT FOR ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-090) LOT 409383 AND ITS COMPONENTS. THE CAPA REVIEW IDENTIFIED ONE NONCONFORMANCE DOCUMENTING THE SAME ISSUE OF PRODUCING AN ELEVATED RATE OF REACTIVE NEGATIVE CONTROLS (NEGATIVE CONTROL IS REACTIVE) AND DISCREPANT RESULTS FOR THE RESPIRATORY SYNCYTIAL VIRUS (RSV) AND FLU B ANALYTE WITH THE SAME LOT AS REPORTED IN THIS INVESTIGATION. COMPLAINT TICKET WAS DISPOSITIONED AS CONFIRMED. FIELD ACTION FA-AM-APR2025-307 WAS ISSUED ON APRIL 28, 2025 TO INFORM CUSTOMERS THAT ABBOTT HAS RECEIVED REPORTS OF AN INCREASE IN REACTIVE NEGATIVE CONTROLS AND FALSE POSITIVE RESULTS, WITH ALINITY M RESP-4-PLEX AMP KIT, LIST NUMBER 09N79-090 LOT NUMBERS 409383, 410627, AND 411921, AND LIST 09N79-096 LOT NUMBER 409384 ON THE ALINITY M SYSTEM. SPECIFICALLY, AN INCREASE IN THE AMOUNT OF REACTIVE NEGATIVE CONTROLS AND FALSE POSITIVE RESULTS HAVE BEEN REPORTED FOR THE RESPIRATORY SYNCYTIAL VIRUS (RSV) AND INFLUENZA B VIRUS (FLU B) AND TARGETS. BASED ON INTERNAL EVALUATION, FALSE POSITIVE RESULTS AND REACTIVE NEGATIVE CONTROLS MANIFEST AS A WEAK SIGNAL WITH A LATE CYCLE NUMBER FOR THESE TARGETS. INTERNAL EVALUATION HAS NOT SHOWN IMPACT TO INFLUENZA A VIRUS (FLU A) AND SARS TARGETS. THERE IS A POTENTIAL FOR DELAYED RESULTS AND FALSE POSITIVE RESULTS FOR RSV AND FLU B WHEN USING THESE LOTS. ALL SUBSEQUENT LOTS OF ALINITY M RESP-4-PLEX AMP KITS ARE NOT IMPACTED. FOR INCORRECT RSV AND FLUB RESULTS ON THE ALINITY M RESP-4-PLEX ASSAY, ASSOCIATED SEVERITY IS MODERATE. THE FOLLOWING MDRS WERE ALSO REPORTED AS RELATED TO FA-AM-APR2025-307: 3005248192-2025-00064 FOLLOW UP REPORT 1, 3005248192-2025-00075 FOLLOW UP REPORT 1, 3005248192-2025-00143, 3005248192-2025-00144, 3005248192-2025-00145, 3005248192-2025-00146, 3005248192-2025-00147, 3005248192-2025-00148, 3005248192-2025-00149, 3005248192-2025-00150, 3005248192-2025-00151, 3005248192-2025-00152, 3005248192-2025-00153, 3005248192-2025-00010 FOLLOW UP REPORT 1, 3005248192-2025-00046 FOLLOW UP REPORT 1, 3005248192-2025-00032 FOLLOW UP REPORT 1, 3005248192-2025-00081 FOLLOW UP REPORT 1, 3005248192-2025-00082 FOLLOW UP REPORT 1, 3005248192-2025-00083 FOLLOW UP REPORT 1, 3005248192-2025-00084 FOLLOW UP REPORT 1, 3005248192-2025-00085 FOLLOW UP REPORT 1, 3005248192-2025-00094 FOLLOW UP REPORT 1, 3005248192-2025-00095 FOLLOW UP REPORT 1, 3005248192-2025-00096 FOLLOW UP REPORT 1, 3005248192-2025-00097 FOLLOW UP REPORT 1, 3005248192-2025-00098 FOLLOW UP REPORT 1, 3005248192-2025-00048 FOLLOW UP REPORT 1, 3005248192-2025-00049 FOLLOW UP REPORT 1, 3005248192-2025-00050 FOLLOW UP REPORT 1, 3005248192-2025-00051 FOLLOW UP REPORT 1, 3005248192-2025-00052 FOLLOW REPORT 1, 3005248192-2025-00053 FOLLOW REPORT 1, 3005248192-2025-00016 FOLLOW UP REPORT 1, 3005248192-2025-00017 FOLLOW UP REPORT 1, 3005248192-2025-00018 FOLLOW UP REPORT 1, 3005248192-2025-00019 FOLLOW UP REPORT 1, 3005248192-2025-00020 FOLLOW UP REPORT 1, 3005248192-2025-00021 FOLLOW UP REPORT 1, 3005248192-2025-00022 FOLLOW UP REPORT 1, 3005248192-2025-00023 FOLLOW UP REPORT 1, 3005248192-2025-00024 FOLLOW UP REPORT 1, 3005248192-2025-00025 FOLLOW UP REPORT 1, 3005248192-2025-00026 FOLLOW UP REPORT 1, 3005248192-2025-00027 FOLLOW UP REPORT 1, 3005248192-2025-00028 FOLLOW UP REPORT 1, 3005248192-2025-00042 FOLLOW UP REPORT 1, 3005248192-2025-00078 FOLLOW UP REPORT 1, 3005248192-2025-00079 FOLLOW UP REPORT 1, 3005248192-2025-00080 FOLLOW UP REPORT 1, 3005248192-2025-00139 FOLLOW UP REPORT 1, 3005248192-2025-00140 FOLLOW UP REPORT 1, 3005248192-2025-00141 FOLLOW UP REPORT 1, 3005248192-2025-00142 FOLLOW UP REPORT 1, 3005248192-2025-00110 FOLLOW UP REPORT 1, 3005248192-2025-00111 FOLLOW UP 01, 3005248192-2025-00112 FOLLOW UP REPORT 1, 3005248192-2025-00117 FOLLOW UP REPORT 1, 3005248192-2025-00118 FOLLOW UP REPORT 1, 3005248192-2025-00119 FOLLOW UP REPORT 1 , 3005248192-2025-00204, 3005248192-2025-00205, 3005248192-2025-00130 FOLLOW UP REPORT 1, 3005248192-2025-00171 FOLLOW UP REPORT 1, 3005248192-2025-00172 FOLLOW UP 01, 3005248192-2025-00173 FOLLOW UP 01, 3005248192-2025-00174 FOLLOW UP 01, 3005248192-2025-00175 FOLLOW UP 01, 3005248192-2025-00176 FOLLOW UP 01, 3005248192-2025-00177 FOLLOW UP 01, 3005248192-2025-00178 FOLLOW UP 01, 3005248192-2025-00179 FOLLOW UP 01, 3005248192-2025-00180 FOLLOW UP 01, 3005248192-2025-00181 FOLLOW UP 01, 3005248192-2025-00168 FOLLOW UP REPORT 1, 3005248192-2025-00169 FOLLOW UP REPORT 1, 3005248192-2025-00170 FOLLOW UP REPORT 1.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE ALINITY M RESP-4-PLEX RESULTS ON THE ALINITY M SYSTEM. SAMPLE IDS (SID) (B)(6) WERE POSITIVE FOR RSV. THE CUSTOMER SUSPECTED RSV CONTAMINATION FROM THEIR RESP-4-PLEX ASSAY BECAUSE OF REACTIVE NEGATIVE CONTROLS ON THEIR OTHER ALINITY M INSTRUMENT. THE CUSTOMER THEN RETESTED THESE 3 PATIENTS ON THEIR BIOFIRE PLATFORM AND THOSE RESULTS WERE NEGATIVE, PROVING TO BE DISCREPANT. ALL SAMPLES WERE IMMEDIATELY ALIQUOTED AND RETESTED ON BIOFIRE AFTER RECEIVING POSITIVE RESULTS. RESULTS WERE NOT YET COMMUNICATED TO PATIENTS, BUT THE CUSTOMER NOTED THAT THEY WILL REPORT IT AS "INCONCLUSIVE." THE CUSTOMER ALSO RECEIVED POSITIVE RSV RESULTS FOR THE FOLLOWING 3 SAMPLES BUT DID NOT GET A CHANCE TO TEST THEM ON THE BIOFIRE YET: (B)(6). THERE WERE ONLY 3 DISCREPANT RESULTS CONFIRMED- SAMPLE IDS (SID) (B)(6). THE POSITIVE SAMPLES WERE IMMEDIATELY ALIQUOTED AND RETESTED ON BIOFIRE AFTER RECEIVING POSITIVE RESULTS ON ALINITY. THE CUSTOMER BELIEVED THESE RESULTS TO BE FALSE POSITIVE, BECAUSE THE BIOFIRE RESULTS WERE NEGATIVE. BY THEIR PROTOCOL, THE CUSTOMER NOTED THAT THEY WILL REPORT IT AS "INCONCLUSIVE." THE CUSTOMER STATED THAT THE RESULT DID NOT IMPACT PATIENT MANAGEMENT. THE CUSTOMER PERFORMED MAINTENANCE AND TESTED WATER SAMPLES WHICH CAME UP POSITIVE FOR RSV. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE DETERMINED THAT THE ROOT CAUSE ANALYSIS FOR THE CONTAMINATION EVENT WAS DUE TO BROKEN MAG BAR 4. THE INSTRUMENT WAS REPAIRED AND ALL CHECKS AND VERIFICATIONS PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413493 ALINITY M RESP-4-PLEX AMP KIT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT MOLECULAR, INC. 409384 00884999049390

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown