BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M RESP-4-PLEX AMP KIT

    MDR report key: 20670866 · Received November 13, 2024

    Report

    Report Number
    3005248192-2024-00189
    Event Type
    Malfunction
    Date Received
    November 13, 2024
    Date of Event
    October 12, 2024
    Report Date
    December 18, 2024
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    QJR
    UDI-DI
    00884999049390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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: 3005248192-2024-00190, OCCURRENCE DATE (B)(6)2024.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS COMPLAINT INCLUDED A CUSTOMER DATA REVIEW, RETAIN/FILE SAMPLE REVIEW, A QUALITY DATA REVIEW, AND A COMPLAINT HISTORY REVIEW. INVESTIGATION IS SUMMARIZED AS FOLLOWS CUSTOMER DATA REVIEW: THE VALIDITY OF RUNS WAS VERIFIED. THE RUNS INVOLVING REPORTED SAMPLES WERE VALID, MET ASSAY SPECIFICATION REQUIREMENTS, AND NO ERROR CODES OR FLAGS WERE DISPLAYED. THE AMPLIFICATION CURVES APPEARED NORMAL FOR NEGATIVE SAMPLES AND EXHIBITED NORMAL AMPLIFICATION OF THE INTERNAL CONTROL FOR THE 3 REPORTED SIDS. DIFFERENT PLATFORMS MAY HAVE DIFFERENT SENSITIVITIES FOR THE ASSAY; THEREFORE, RESULTS ARE NOT COMPARABLE BETWEEN THE TWO PLATFORMS. THE REVIEW OF THE CUSTOMER DATA DEMONSTRATED THE ALINITY M RESP-4-PLEX AMP KIT (LIST: 09N79-096) LOT: 406017 ARE PERFORMING AS EXPECTED. REVIEW OF THE RESULTS LOG FILES FROM THE CUSTOMER DO NOT INDICATE THAT LOT: 406017 ARE PERFORMING OUTSIDE OF ESTABLISHED DESIGN PERFORMANCE SPECIFICATIONS BASED ON THE ELEMENTS REVIEWED IN THIS SECTION. RESULTS SHOULD BE EVALUATED IN CONJUNCTION WITH OTHER CLINICAL DATA PERTAINING TO THE PATIENT BEFORE ANY TREATMENT MANAGEMENT DECISIONS ARE MADE. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED BY THIS EVALUATION. RETAIN/FILE SAMPLE REVIEW: THE FILE SAMPLE EVALUATION FOR ALINITY M RESP-4-PLEX AMP KIT (LIST: 09N79-096) LOT: 406017 WAS PERFORMED AND ALL TESTING MET THE ACCEPTANCE CRITERIA WITH A PASS DISPOSITION. THERE WERE NO INSTANCES OF FALSE NEGATIVE RESULTS DETECTED. THE ASSAY MEETS SPECIFICATION REQUIREMENTS, AND NO ERROR CODES OR FLAGS WERE DISPLAYED FOR THE RUN CONTROLS. FILE SAMPLE TESTING FOR ALINITY M RESP-4-PLEX AMP KIT (LIST: 09N79-096) LOT: 406017 RECEIVED A DISPOSITION OF PASS WITH A 100% SPECIFICITY FOR THE TEST. THEREFORE, THE FILE SAMPLE EVALUATION TESTING RESULTS DID NOT REPRODUCE THE CUSTOMER'S OBSERVATIONS. QUALITY DATA REVIEW: DEVICE HISTORY RECORD / BATCH RECORD REVIEW: REVIEW OF THE MANUFACTURING PACKET FOR ALINITY M RESP-4-PLEX AMP KIT (LIST: 09N79-096) LOT: 406017 (INCLUDING THE COMPONENTS) DID NOT IDENTIFY ANY ISSUES WHICH COULD RESULT IN THE REPORTED COMPLAINT. THE QUALITY CONTROL (QC) AMP KIT MASTERLOT TESTING FOR THE ALINITY M RESP-4-PLEX AMP KIT (LIST: 09N79-096) LOT: 406017 MET ALL VALIDITY AND ACCEPTANCE CRITERIA. NO ISSUES RELATED TO THE REPORTED COMPLAINT WERE REPORTED DURING QC TESTING. 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: 09N79-096) LOT: 406017 AND ITS COMPONENTS. THE CAPA REVIEW FOR LOT NUMBERS: 406017 & 4060171 DID NOT IDENTIFY ANY EXISTING INTERNAL ISSUES OR RECORDS THAT MAY BE RELATED TO THE REPORTED COMPLAINT. COMPLAINT HISTORY REVIEW: A LOT SPECIFIC COMPLAINT HISTORY REVIEW WAS PERFORMED TO IDENTIFY ANY SIMILAR COMPLAINTS TO THE TICKET BEING INVESTIGATED. THE COMPLAINT HISTORY REVIEW DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS RELATED TO THE REPORTED ISSUE FOR ALINITY M RESP-4-PLEX AMP KIT (LIST: 09N79-96) LOT: 406017. COMPLAINT TRENDING WAS COMPLETED. A TREND VIOLATION WAS NOT IDENTIFIED, AND THE UPPER CONTROL LIMIT WAS NOT EXCEEDED FOR PART: 09N79 (TRENDING PART NUMBER). BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY WAS NOT IDENTIFIED BY THIS EVALUATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 3 FALSE NEGATIVE RESULTS FOR THE FLU A TARGET ON THE ALINITY M RESP-4-PLEX AMP KIT. THE CUSTOMER HAD RETESTED THE SAMPLES ON THE CEPHEID PLATFORM, AND THE RESULTS WERE POSITIVE FOR THE FLU A ANALYTE ON CEPHEID WHILE THE FLU A TARGET WAS NEGATIVE ON THE ALINITY. SAMPLE ID (SID) ALINITY M CEPHEID (B)(6) FLU B + FLU A & B + (B)(6) FLU B + FLU B +, A NEGATIVE WITH CYCLE NUMBER (CN) AROUND 40. (B)(6) FLU B+ FLU A & B + THE FOLLOWING CYCLE NUMBERS WERE THE NUMBERS THAT WERE ELICITED ON THE CEPHEID: (B)(6): (B)(6): FLU A CYCLE 36.6; NOT REPORTED, ASKED FOR RECOLLECTION - ANALYZER ISSUE. (B)(6): (B)(6): FLU A CYCLE 36.1; NOT REPORTED, ASKED FOR RECOLLECTION - ANALYZER ISSUE. (B)(6): (B)(6): FLU A CYCLE 35.1; NOT REPORTED, ASKED FOR RECOLLECTION - ANALYZER ISSUE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT AS THE RESULTS WERE NOT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 3 FALSE NEGATIVE RESULTS FOR THE FLU A TARGET ON THE ALINITY M RESP-4-PLEX AMP KIT. THE CUSTOMER HAD RETESTED THE SAMPLES ON THE CEPHEID PLATFORM, AND THE RESULTS WERE POSITIVE FOR THE FLU AN ANALYTE ON CEPHEID WHILE THE FLU A TARGET WAS NEGATIVE ON THE ALINITY. SAMPLE ID (SID), ALINITY M, CEPHEID , (B)(6), FLU B +, FLU A & B +, (B)(6), FLU B+, FLU A & B +, (B)(6), FLU B+, FLU A & B +. THE FOLLOWING CYCLE NUMBERS WERE THE NUMBERS THAT WERE ELICITED ON THE CEPHEID: 10/12: (B)(6): FLU A CYCLE 36.6; NOT REPORTED, ASKED FOR RECOLLECTION - ANALYZER ISSUE. 10/12: (B)(6): FLU A CYCLE 36.1; NOT REPORTED, ASKED FOR RECOLLECTION - ANALYZER ISSUE. 10/17: (B)(6): FLU A CYCLE 35.1; NOT REPORTED, ASKED FOR RECOLLECTION - ANALYZER ISSUE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT AS THE RESULTS WERE NOT REPORTED. DURING A FOLLOW-UP, THE MOLECULAR APPLICATION SPECIALIST AND CUSTOMER CONFIRMED SID: (B)(6) WAS NOT CONSIDERED DISCREPANT. THE FOLLOWING SIDS WERE CONSIDERED FALSE NEGATIVE: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084860 ALINITY M RESP-4-PLEX AMP KIT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT MOLECULAR, INC. 406017 00884999049390

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown