BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M HR HPV AMP KIT

    MDR report key: 18704407 · Received February 14, 2024

    Report

    Report Number
    3005248192-2024-00048
    Event Type
    Malfunction
    Date Received
    February 14, 2024
    Date of Event
    February 5, 2024
    Report Date
    May 15, 2024
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    MAQ
    PMA / PMN Number
    P230003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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 HR HPV ASSAY, LIST NUMBER 09N15-090, WHICH IS THE SAME/SIMILAR TO THE ALINITY M HR HPV ASSAY, LIST NUMBER 09N15-095, WHICH RECEIVED FDA APPROVAL.

    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 HR HPV AMP KIT (LIST 09N15-090) LOT 389542. THE VALIDITY OF THE RUNS, INCLUDING MEETING ASSAY SPECIFICATION REQUIREMENTS, WAS VERIFIED. CUSTOMER DATA REVIEW CUSTOMER RESULT LOG FILES WERE REVIEWED. THE RUNS WHICH INVOLVED THE DISCREPANT RESULTS WERE VALID AND MET ASSAY SPECIFICATION REQUIREMENTS. THE VALIDITY OF THE RUN MET ASSAY SPECIFICATION REQUIREMENTS. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED FROM THIS ANALYSIS. QUALITY DATA REVIEW DEVICE HISTORY RECORD / BATCH RECORD REVIEW: THE DEVICE HISTORY RECORDS (DHR) REVIEW FOR ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT 389542 (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. CAPA / NON-CONFORMANCE REVIEW: THE CAPA REVIEW FOR ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT 389542 (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 THESE LOTS. 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 HR HPV AMP KIT (LIST 09N15-090) LOT 389542. NO NEW ADVERSE TREND WAS IDENTIFIED. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED BY THIS EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT 389542 WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A DISCREPANT RESULT ON THE ALINITY M HR HPV AMP KIT. SID (SAMPLE ID) (B)(6) WAS RAN ON (B)(6) 2024 AND THE INITIAL RESULT WAS NOT DETECTED. UPON REVIEWING THE CURVES, THE SAMPLE WAS REPEATED ON (B)(6) 2024 AND THE RESULT WAS DETECTED FOR HPV 45 AND OTHER B. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389924 ALINITY M HR HPV AMP KIT KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS MAQ ABBOTT MOLECULAR, INC. 389542

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown