BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M RESP-4-PLEX AMP KIT

    MDR report key: 21704636 · Received March 27, 2025

    Report

    Report Number
    3005248192-2025-00074
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    March 6, 2025
    Report Date
    June 27, 2025
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    QJR
    UDI-DI
    00884999049338
    Removal / Correction Number
    3005248192-04/28/25-002-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. AS THE EVENT OCCURRED OVER MULTIPLE RUN DATES, THE FOLLOWING MDRS HAVE BEEN SUBMITTED WITH THE FOLLOWING DATE OF OCCURRENCES: 3005248192-2025-00066, OCCURRENCE DATE 23-FEB-25, 3005248192-2025-00067, OCCURRENCE DATE 24-FEB-25, 3005248192-2025-00068, OCCURRENCE DATE 26-FEB-25, 3005248192-2025-00069, OCCURRENCE DATE 27-FEB-25, 3005248192-2025-00070, OCCURRENCE DATE 28-FEB-25, 3005248192-2025-00071, OCCURRENCE DATE 03-MAR-25, 3005248192-2025-00072, OCCURRENCE DATE 04-MAR-25, 3005248192-2025-00073, OCCURRENCE DATE 05-MAR-25, OCCURRENCE DATE (B)(6)2025.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS COMPLAINT IS 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, 3005248192-2025-00038 FOLLOW UP REPORT 2, 3005248192-2025-00103 FOLLOW UP 01, 3005248192-2025-00104 FOLLOW UP 01, 3005248192-2025-00105 FOLLOW UP 01, 3005248192-2025-00106 FOLLOW UP 01, 3005248192-2025-00107 FOLLOW UP 01, 3005248192-2025-00108 FOLLOW UP 01, 3005248192-2025-00109 FOLLOW UP 01, 3005248192-2025-00182, 3005248192-2025-00120 FOLLOW UP REPORT 1, 3005248192-2025-00227, 3005248192-2025-00228, 3005248192-2025-00066 FOLLOW UP 01, 3005248192-2025-00067 FOLLOW UP 01, 3005248192-2025-00068 FOLLOW UP 01, 3005248192-2025-00069 FOLLOW UP 01, 3005248192-2025-00070 FOLLOW UP 01, 3005248192-2025-00071 FOLLOW UP 01, 3005248192-2025-00072 FOLLOW UP 01, 3005248192-2025-00073 FOLLOW UP 01.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS FOR THE RSV TARGET ON THE ALINITY M RESP 4-PLEX AMP KIT. THE CUSTOMER ORIGINALLY REPORTED THAT 53 SAMPLES SINCE (B)(6) 2025 TESTED POSITIVE FOR RSV, AND ANYTHING OVER 39 CYCLE NUMBER (CN) WAS RETESTED ON THE GENEXPERT. ALL SAMPLE RETESTED ON THE GENEXPERT HAD A NEGATIVE RESULT. TAS ASKED CUSTOMER FOR A LIST OF SAMPLE IDS AND CUSTOMER WILL PROVIDE A LIST. ALL SAMPLES REPORTED AS DISCREPANT WERE TESTED ON RESP 4-PLEX AMP KIT. NONE OF THE RETESTED SAMPLES WERE REPORTED OUT OF THE LAB. CUSTOMER REPORTED THAT THEY AUTOMATICALLY RETEST ANY SAMPLE WITH A POSITIVE CN OVER 39. THE FOLLOWING SAMPLES WERE RETESTED AND RESULTED AS NEGATIVE: DATE: SAMPLEID: RESULT: ON (B)(6) 2025, (B)(6), 39.55 CN, ON (B)(6) 2025, (B)(6), 40.82 CN, ON (B)(6) 2025, (B)(6), 39.54 CN, ON (B)(6) 2025, (B)(6), 39.13 CN, ON (B)(6) 2025, (B)(6), 40.01 CN, ON (B)(6) 2025, (B)(6), 40.20 CN, ON (B)(6) 2025, (B)(6), 41.45 CN, ON (B)(6) 2025, (B)(6), 40.99 CN, ON (B)(6) 2025, (B)(6), 41.81 CN, ON (B)(6) 2025, (B)(6), 41.38 CN, ON (B)(6) 2025, (B)(6), 39.56 CN, ON (B)(6) 2025, (B)(6), 41.06 CN, ON (B)(6) 2025, (B)(6), 40.44 CN, ON (B)(6) 2025, (B)(6), 40.57 CN, ON (B)(6) 2025, (B)(6), 39.63 CN, ON (B)(6) 2025, (B)(6), 39.97 CN, ON (B)(6) 2025, (B)(6), 41.12 CN, ON (B)(6) 2025, (B)(6), 39.40 CN, ON (B)(6) 2025, (B)(6), 40.65 CN, ON (B)(6) 2025, (B)(6), 39.45 CN, ON (B)(6) 2025, (B)(6), 39.33 CN, ON (B)(6) 2025, (B)(6), 40.18 CN, ON (B)(6) 2025, (B)(6), 40.32 CN, ON (B)(6) 2025, (B)(6), 41.74 CN, ON (B)(6) 2025, (B)(6), 40.05 CN, ON (B)(6) 2025, (B)(6), 40.79 CN, ON (B)(6) 2025, (B)(6), 40.88 CN, ON (B)(6) 2025, (B)(6), 41.54 CN, ON (B)(6) 2025, (B)(6), 41.86 CN, ON (B)(6) 2025, (B)(6), 40.23 CN, ON (B)(6) 2025, (B)(6), 39.33 CN, ON (B)(6) 2025, (B)(6), 41.32 CN, ON (B)(6) 2025, (B)(6), 41.67 CN, ON (B)(6) 2025, (B)(6), 41.26 CN. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO DISCREPANT POSITIVE RESULTS WERE REPORTED OUT OF THE LAB. THE CUSTOMER REPORTED A TOTAL OF 34 DISCREPANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471489 ALINITY M RESP-4-PLEX AMP KIT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT MOLECULAR, INC. 409384 00884999049338

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown