BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M RESP-4-PLEX AMP KIT

    MDR report key: 23066995 · Received September 16, 2025

    Report

    Report Number
    3005248192-2025-00315
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    July 30, 2025
    Report Date
    November 5, 2025
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    QJR
    UDI-DI
    00884999049338
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED INTERNATIONALLY USING THE ALINITY M RESP-4-PLEX ASSAY, LIST LIST NUMBER 09N79-090, WHICH IS THE SAME/SIMILAR TO THE ALINITY M RESP-4-PLEX ASSAY, LIST NUMBER 09N79-096, WHICH RECEIVED FDA EUA APPROVAL AND THE ALINITY M RESP-4-PLEX ASSAY, LIST NUMBER 09N79-095, WHICH RECEIVED FDA APPROVAL. ADDITIONAL MDRS SUBMITTED FOR ADDITIONAL RUN DATES: 3005248192-2025-00307 08/24/2025, 3005248192-2025-00308 08/21/2025, 3005248192-2025-00309 08/20/2025, 3005248192-2025-00310 08/14/2025, 3005248192-2025-00311 08/12/2025, 3005248192-2025-00312 08/09/2025, 3005248192-2025-00313 08/08/2025, 3005248192-2025-00314 08/07/2025, (B)(6) 2025, 3005248192-2025-00316 07/29/2025, 3005248192-2025-00317 07/27/2025, 3005248192-2025-00318 07/22/2025, 3005248192-2025-00319 07/21/2025, 3005248192-2025-00320 07/19/2025, 3005248192-2025-00321 07/13/2025, 3005248192-2025-00322 07/11/2025.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS SUMMARIZED AS FOLLOWS: CUSTOMER DATA REVIEW: THE AVAILABLE CUSTOMER DATA WAS REVIEWED. THE ASSAY MET SPECIFICATION REQUIREMENTS AS NO ERROR CODES OR FLAGS WERE DISPLAYED FOR THE AVAILABLE QUALITY CONTROL (QC) RUNS FOR THE REPORTED SAMPLES, INDICATING THE ALINITY M REAGENTS ARE PERFORMING AS INTENDED. DIFFERENT PLATFORMS HAVE DIFFERENT SENSITIVITIES AND SPECIFICITIES FOR THE ASSAY. THEREFORE, THE RESULTS REPORTED ON THE ALINITY M SYSTEM MAY NOT ALWAYS AGREE WITH OTHER TECHNOLOGIES. QUALITY DATA REVIEW: DEVICE HISTORY RECORD / BATCH RECORD REVIEW: REVIEW OF THE MANUFACTURING PACKET FOR ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-090) LOT 414712 DID NOT IDENTIFY ANY ISSUES THAT COULD HAVE LED TO THE REPORTED COMPLAINT. THE QUALITY CONTROL (QC) AMP KIT MASTER LOT TESTING FOR ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-090) LOT 414712 MET ALL VALIDITY AND ACCEPTANCE CRITERIA. NO ISSUES RELATED TO THE REPORTED COMPLAINT WERE REPORTED DURING QC TESTING. REVIEW OF THE MANUFACTURING PACKET FOR ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-090) LOT 414709 DID NOT IDENTIFY ANY ISSUES THAT COULD HAVE LED TO THE REPORTED COMPLAINT. THE QUALITY CONTROL (QC) AMP KIT MASTER LOT TESTING FOR ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-090) LOT 414709 MET ALL VALIDITY AND ACCEPTANCE CRITERIA. NO ISSUES RELATED TO THE REPORTED COMPLAINT WERE REPORTED DURING QC TESTING. CAPA / NON-CONFORMANCE REVIEW A LOT SPECIFIC CAPA SEARCH WAS PERFORMED TO IDENTIFY RELATED EXISTING INTERNAL QUALITY RECORDS TO THE REPORTED COMPLAINT DURING PRODUCTION OR INTERNAL USE. LOTS 414712, 4147121, 414709, AND 4147091 WERE SEARCHED. A PART SPECIFIC KEYWORD SEARCH REPORT WAS PERFORMED FOR PART 9N79 TO IDENTIFY ANY EXISTING INTERNAL QUALITY RECORDS THAT COULD RESULT IN THE REPORTED COMPLAINT DURING PRODUCTION OR INTERNAL USE RECORDS THAT WERE RELATED TO THE REPORTED COMPLAINT AND PART. THE CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS DID NOT IDENTIFY RELATED RECORDS AND DID NOT IDENTIFY A DEFICIENCY. RETAIN / FILE SAMPLE REVIEW THE FILE SAMPLE EVALUATION FOR ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-090) LOT 414712 WAS PERFORMED. THE QC TESTING FOR ALINITY M RESP-4-PLEX AMP KIT LIST 09N79-090 LOT 414712 MET ALL VALIDITY CRITERIA AND ACCEPTANCE CRITERIA FOR ALL FOUR ANALYTES. THE DISPOSITION IS A PASS. THE FILE SAMPLE EVALUATION FOR THE ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-090) LOT NUMBER 414709 WAS PERFORMED. THE FILE SAMPLE EVALUATION MET ALL VALIDITY AND ACCEPTANCE CRITERIA. THE FILE SAMPLE EVALUATION FOR LOT 414709 MET THE ACCEPTANCE AND VALIDITY CRITERIA THAT WAS ESTABLISHED. AS A RESULT, THE PRODUCT FILE SAMPLE EVALUATION FOR THE ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-090) LOT NUMBER 414709 RECEIVED A DISPOSITION OF PASS. COMPLAINT HISTORY REVIEW A LOT SPECIFIC COMPLAINT HISTORY REVIEW WAS PERFORMED TO IDENTIFY ANY SIMILAR COMPLAINTS TO THE CASE BEING INVESTIGATED IN WHICH REPORTED DISCREPANT FALSE POSITIVE RESULTS FOR THE RSV ANALYTE WHILE USING ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-090) LOT NUMBERS 414712 AND 414709. THE COMPLAINT HISTORY REVIEW DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS RELATED TO THE REPORTED ISSUE FOR ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-090) LOT NUMBER 414709. COMPLAINT TRENDING WAS COMPLETED. A TREND VIOLATION WAS NOT IDENTIFIED AS THE UPPER CONTROL LIMIT WAS NOT EXCEEDED FOR PRODUCT 9N79 (BASE LIST PART NUMBER). BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-090) LOT NUMBERS 414712 AND 414709 WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY HAVE OBSERVED AN INCREASE OF POSITIVE RESULT FOR THE RSV TARGET ON THE ALINITY M RESP-4-PLEX ASSAY FOR THE PAST SINCE (B)(6) 2025. CUSTOMER REPORTED THAT THEY SYSTEMATICALLY RETEST EVERY RESULT FOR CYCLE THRESHOLD (CT) ABOVE 35 ON THE GENEXPERT PLATFORM. SO FAR, NO RESULTS HAVE BEEN CONFIRMED. NO RESULTS WERE REPORTED TO THE PHYSICIAN AND THERE WAS NO IMPACT TO PATIENT MANAGEMENT. THE CUSTOMER DID NOT PROVIDE SAMPLE IDS (SIDS), THEY JUST REPORTED A TREND AND BELIEVE THE ISSUE WAS RELATED TO PREVIOUS ISSUE THEY HAD WITH THE AMP KIT. THE TECHNICAL APPLICATION SPECIALIST (TAS) IDENTIFIED 17 SAMPLES WITH A CT ABOVE 35 OVER 2 LOT NUMBERS ON THE ALINITY M RESP-4-PLEX AMP KIT (414712, 414709). RERUNNING SAMPLES ON A SECONDARY ASSAY DID HAVE A DIRECT IMPACT ON PATIENTS BY DELAYING RESULTS BEING REPORTED. THERE HAS BEEN NO REPORT OF IMPACT TO PATIENT MANAGEMENT. THIS EVENT HAS BEEN CONSIDERED FALSE POSITIVE RESULTS FOR THE RSV TARGET. ADDITIONAL INFORMATION PROVIDED 08-SEP-2025: CUSTOMER REPORTED THE NEGATIVE RESULT FROM GENEXPERT TO THE PHYSICIAN. THE REPORTED DELAY WAS IN RECEIVING THE INFORMATION. NO IMPACT TO PATIENT MANAGEMENT. COMPLETEDDATE: SAMPLEID: TARGETRESPONSE: AMPKITLOT : (B)(6) 2025 , (B)(6), 40.5 , 414709 , (B)(6) 2025 , (B)(6), 41.03, 414709 , (B)(6) 2025 , (B)(6), 40.97, 414709 , (B)(6) 2025 , (B)(6), 40.76, 414712 , (B)(6) 2025 , (B)(6), 41.27 , 414712 , (B)(6) 2025 , (B)(6), 40.96 , 414712 , (B)(6) 2025, (B)(6), 35.35 , 414712, (B)(6) 2025, (B)(6), 40.25 , 414712 , (B)(6) 2025 , (B)(6), 39.95, 414712, (B)(6) 2025 , (B)(6), 40.9 , 414712, (B)(6) 2025, (B)(6) 41.17 , 414712, (B)(6) 2025, (B)(6), 39.92 , 414712, (B)(6) 2025 , (B)(6), 39.72 , 414712, (B)(6) 2025 , (B)(6), 40.49, 414712, (B)(6) 2025 , (B)(6), 41.01 , 414712, (B)(6) 2025 , (B)(6), 41.33 , 414712 , (B)(6) 2025 , (B)(6), 40.85 , 414712.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2681071 ALINITY M RESP-4-PLEX AMP KIT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT MOLECULAR, INC. 414712 00884999049338

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown