BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M HR HPV AMP KIT

    MDR report key: 18478307 · Received January 9, 2024

    Report

    Report Number
    3005248192-2024-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    December 28, 2023
    Report Date
    February 22, 2024
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    MAQ
    UDI-DI
    00884999047921
    PMA / PMN Number
    P230003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS UPDATED D4 UDI FROM (B)(4). 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 385721. CUSTOMER DATA REVIEW CUSTOMER RESULT LOG FILES WERE REVIEWED. THE RUNS WHICH INVOLVED THE DISCREPANT RESULTS WERE VALID AND MET ASSAY SPECIFICATION REQUIREMENTS. A PRODUCT DEFICIENCY COULD NOT BE 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 385721 (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 HR HPV AMP KIT (LIST 09N15-090) LOT 385721 (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 HR HPV AMP KIT (LIST 09N15-090) LOT 385721. A TREND VIOLATION FOR LIST 09N15 WAS NOT 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 385721 WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 0

    ELEVATED COMPLAINT INVESTIGATION WILL BE INITIATED. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN POLAND 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. THE FOLLOWING ADDITIONAL MDR HAS ALSO BEEN SUBMITTED WITH THE FOLLOWING SUSPECT PRODUCT: 3005248192-2024-00002, WITH SUSPECT PRODUCT ALINITY M SYSTEM LIST NUMBER 08N53-002 SERIAL NUMBER (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 4 FALSE NOT DETECTED RESULTS ON THE ALINITY M HR HPV AMP KIT. SID (SAMPLE ID) (B)(6) WAS PROCESSED ON (B)(6) 2023 AND GAVE A RESULT OF "NOT DETECTED". THE SAMPLE WAS RETESTED THE SAME DAY DUE TO "NON-SIGMOIDAL" SHAPE OF THE "OTHER B" TARGET AND GAVE A RESULT OF "OTHER B" DETECTED. SID (B)(6) WAS PROCESSED ON (B)(6) 2023 AND GAVE A RESULT OF "NOT DETECTED". THE SAMPLE WAS RETESTED THE SAME DAY DUE TO SIGNAL RAISE AFTER CYCLE 30 AND GAVE A RESULT OF "HPV 18" DETECTED. SID (B)(6) WAS PROCESSED ON (B)(6) 2023 AND GAVE A RESULT OF "NOT DETECTED". THE SAMPLE WAS RETESTED THE SAME DAY DUE TO SIGNAL OF HPV 45 NOT BEING RECOGNIZED BY THE ALINITY M SOFTWARE. THE SAMPLE WAS RETESTED ON (B)(6) 2023 AND GAVE A RESULT OF "HPV 45; OTHER B" DETECTED. SID (B)(6) WAS PROCESSED ON (B)(6) 2023 AND GAVE A RESULT OF "NOT DETECTED". THE SAMPLE WAS RETESTED FOR THE FIRST TIME ON (B)(6) 2023 DUE TO "NON-SIGMOIDAL" SHAPE OF "OTHER B" TARGET" AND AGAIN ON (B)(6) 2023 DUE TO APPEARANCE OF STRONG "HPV 18" SIGNAL. RESULT FOR SAMPLE SID( B)(6) WAS RELEASED AS POSITIVE FOR "OTHER B". RESULT FOR SID (B)(6) WAS RELEASED AS POSITIVE FOR "HPV 18". RESULT FOR SID (B)(6) WAS RELEASED AS POSITIVE FOR "HPV 45; OTHER B". RESULT FOR SID (B)(6) WAS RELEASED AS POSITIVE FOR "HPV 18". THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462554 ALINITY M HR HPV AMP KIT KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS MAQ ABBOTT MOLECULAR, INC. 385721 00884999047921

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown