BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M RESP-4-PLEX AMP KIT

    MDR report key: 18616931 · Received January 31, 2024

    Report

    Report Number
    3005248192-2024-00021
    Event Type
    Malfunction
    Date Received
    January 31, 2024
    Date of Event
    January 5, 2024
    Report Date
    March 26, 2024
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    QJR
    UDI-DI
    00884999049390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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: MDR RUN DATE 3005248192-2024-00014, 12/5/2023. 3005248192-2024-00015, 12/22/2023. 3005248192-2024-00016, 12/23/2023. 3005248192-2024-00017, 12/28/2023. 3005248192-2024-00018, 12/30/2023. 3005248192-2024-00019, 12/31/2023. 3005248192-2024-00020, 1/1/2024. 3005248192-2024-00021, 1/5/2024. 3005248192-2024-00022, 1/6/2024. 3005248192-2024-00023, 1/11/2024. 3005248192-2024-00024, 1/12/2024. 3005248192-2024-00025, 1/15/2024. 3005248192-2024-00026, 1/16/2024. 3005248192-2024-00027, 1/17/2024. 3005248192-2024-00028, 1/18/2024. 3005248192-2024-00029, 1/19/2024.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS COMPLAINT INCLUDED A CUSTOMER DATA REVIEW, A QUALITY DATA REVIEW AND A COMPLAINT HISTORY REVIEW. INVESTIGATION IS SUMMARIZED AS FOLLOWS: RETAIN SAMPLE EVALUATION THE FILE SAMPLE TESTING DID NOT IDENTIFY A PRODUCT DEFICIENCY FOR THE ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-096) LOT 386601. CUSTOMER DATA REVIEW CUSTOMER RESULT LOG FILES WERE REVIEWED. THE RUNS WHICH INVOLVED THE DISCREPANT RESULT WERE VALID AND MET ASSAY SPECIFICATION REQUIREMENTS. THE VALIDITY OF THE RUN MET ASSAY SPECIFICATION REQUIREMENTS, AND NO ERROR CODES OR FLAGS WERE DISPLAYED FOR THE RUN CONTROLS. DIFFERENT PLATFORMS HAVE DIFFERENT LIMITS OF DETECTION (LOD) THEREFORE, THE RESULTS MAY NOT BE REPRODUCIBLE. THERE IS NO INDICATION THAT THE ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-096) LOT 386601 IS PERFORMING OUTSIDE OF ESTABLISHED DESIGN PERFORMANCE SPECIFICATIONS BASED ON THE ELEMENTS REVIEWED IN THIS SECTION. QUALITY DATA REVIEW DEVICE HISTORY RECORD / BATCH RECORD REVIEW: THE DEVICE HISTORY RECORDS (DHR) REVIEW FOR ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-096) LOT 386601 (INCLUDING THE COMPONENTS) WAS PERFORMED. THE MANUFACTURING PACKETS WERE REVIEWED TO IDENTIFY ANY ISSUES RELATED TO THE REPORTED COMPLAINT DURING PRODUCTION OF THE LOT COMPONENTS. NO ISSUES WERE IDENTIFIED. NO ISSUES WERE FOUND DURING QUALITY CONTROL (QC) TESTING. THE PRODUCTS PASSED QUALITY SPECIFICATIONS AT THE TIME OF RELEASE. CAPA / NON-CONFORMANCE REVIEW: THE CAPA REVIEW FOR ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-096) LOT 386601 (INCLUDING THE COMPONENTS) WAS PERFORMED TO IDENTIFY ANY RECORDS THAT WERE POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE SEARCH DID NOT IDENTIFY ANY RECORDS RELATED TO THE REPORTED ISSUE FOR THIS LOT NUMBER. COMPLAINT HISTORY REVIEW A LOT SPECIFIC COMPLAINT HISTORY REVIEW WAS PERFORMED TO IDENTIFY ANY SIMILAR COMPLAINTS TO THE TICKET BEING INVESTIGATED, WHICH REPORTED DISCREPANT RESULTS WHILE USING ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-096) LOT 386601. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED BY THIS EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-096) LOT 386601 WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE DETECTED RESULT FOR THE ALINITY M RESP-4-PLEX AMP KIT. SID (SAMPLE ID) (B)(6) TESTED POSITIVE FOR SARS-COV-2 WHEN TESTED ON (B)(6) 2024. WHEN THE SAMPLE WAS RETESTED, THE RESULT WAS NEGATIVE FOR SARS-COV-2. THE FALSE DETECTED RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAS BEEN NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420471 ALINITY M RESP-4-PLEX AMP KIT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT MOLECULAR, INC. 386601 00884999049390

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown