BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M HR HPV AMP KIT

    MDR report key: 20688983 · Received November 14, 2024

    Report

    Report Number
    3005248192-2024-00194
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    August 23, 2024
    Report Date
    December 27, 2024
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    MAQ
    UDI-DI
    00884999047921
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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, RETAIN/FILE SAMPLE REVIEW, A QUALITY DATA REVIEW, AND A COMPLAINT HISTORY REVIEW. INVESTIGATION IS SUMMARIZED AS FOLLOWS: CUSTOMER DATA REVIEW CUSTOMER RESULTS WERE REVIEWED. THE RUNS WERE VALID. THE ASSAY MET SPECIFICATION REQUIREMENTS AS NO ERROR CODES OR FLAGS WERE DISPLAYED FOR THE RUN CONTROLS. THE ASSAY AND SOFTWARE IS PERFORMING CORRECTLY WITH CORRECT INTERPRETATIONS. THERE IS NO INDICATION THAT THE ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT 399449 IS PERFORMING OUTSIDE OF ESTABLISHED DESIGN PERFORMANCE SPECIFICATIONS BASED ON THE ELEMENTS REVIEWED IN THIS SECTION. RETAIN/FILE SAMPLE REVIEW FILE SAMPLE TESTING WAS PERFORMED. A PRODUCT DEFICIENCY COULD NOT BE IDENTIFIED BY THE FILE SAMPLE EVALUATION FOR THE ALINITY M HR HPV ASSAY (LIST 09N15-090) LOT 399449. THE ASSAY REAGENTS PERFORMED AS EXPECTED AND MET THE ASSAY SPECIFICATION REQUIREMENTS WITHOUT ANY ERROR/MESSAGE CODES OR PERFORMANCE RELATED FLAGS ON THE RUN CONTROLS. ALL REPLICATES PASSED AND THERE WERE NO INSTANCES OF FALSE NEGATIVES. QUALITY DATA REVIEW DEVICE HISTORY RECORD / BATCH RECORD REVIEW: REVIEW OF THE MANUFACTURING PACKETS FOR ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT 399449 (INCLUDING THE COMPONENTS) DID NOT IDENTIFY ANY ISSUES WHICH COULD RESULT IN THE REPORTED COMPLAINT. ADDITIONALLY, THE QUALITY CONTROL (QC) TESTING FOR THE ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT 399449 (INCLUDING THE COMPONENTS) MET ALL VALIDITY AND ACCEPTANCE CRITERIA. NO ISSUES RELATED TO THE REPORTED COMPLAINT WERE REPORTED DURING QC TESTING. CAPA / NON-CONFORMANCE REVIEW: A CAPA LOT SEARCH WAS PERFORMED TO IDENTIFY ANY EXISTING INTERNAL QUALITY RECORDS WHICH COULD RESULT IN THE REPORTED COMPLAINT DURING PRODUCTION OR INTERNAL USE. NO EXISTING INTERNAL QUALITY RECORDS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED AS A RESULT OF THIS REVIEW FOR THE REPORTED LOT. COMPLAINT HISTORY REVIEW A COMPLAINT REVIEW WAS PERFORMED TO IDENTIFY ANY SIMILAR COMPLAINTS TO THE TICKET BEING INVESTIGATED FOR ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT 399449. COMPLAINT TRENDING WAS PERFORMED AND DID NOT IDENTIFY A NEW ADVERSE TREND. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED BY THIS EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR THE ALINITY M HR HPV AMP KIT (LIST 09N15-90) LOT 399449 WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 17 FALSE NEGATIVE RESULT WHILE USING THE ALINITY M HIGH RISK (HR) HPV ASSAY. THE CUSTOMER SENT A LIST OF CASES WHERE THE INITIAL TEST RESULT WAS "NOT DETECTED," THE SAMPLE WAS RETESTED DUE TO "ABERRANT" AMPLIFICATION CURVES, AND THE RETEST RESULT WAS POSITIVE FOR HPV. THE CUSTOMER REPORTED THAT ALL THE POSITIVE RESULTS WERE AT THE CLINICAL THRESHOLD. ALL THE SAMPLES WERE CERVICAL SAMPLES IN PRESERVCYT COLLECTION MEDIUM AND WERE MOSTLY FOR SCREENING INDICATIONS. THE CUSTOMER WAS NOT EXPECTING A SPECIFIC RESULT, BUT DID NOT TRUST THE "ABERRANT CURVES." THE CUSTOMER SENT THE SAMPLES FOR CONFIRMATION TO A CYTOPATHOLOGY LAB AND THE SAMPLES ALL CAME OUT WITH A POSITIVE HPV PATTERN. SAMPLE ID: TEST DATE: ALINITY M HR HPV TEST RESULT: (B)(6) (B)(6)2024 NOT DETECTED. (B)(6) (B)(6)2024 HPV 16. SAMPLE ID: TEST DATE: ALINITY M HR HPV TEST RESULT: (B)(6) (B)(6)2024 NOT DETECTED. (B)(6) (B)(6)2024 OTHER HR HPV A. SAMPLE ID: TEST DATE: ALINITY M HR HPV TEST RESULT: (B)(6) (B)(6)2024 NOT DETECTED (B)(6) (B)(6)2024 OTHER HR HPV B SAMPLE ID: TEST DATE: ALINITY M HR HPV TEST RESULT: (B)(6) (B)(6)2024 NOT DETECTED (B)(6) (B)(6)2024 OTHER HR HPV B SAMPLE ID: TEST DATE: ALINITY M HR HPV TEST RESULT: (B)(6) (B)(6)2024 NOT DETECTED (B)(6) (B)(6)2024 OTHER HR HPV B SAMPLE ID: TEST DATE: ALINITY M HR HPV TEST RESULT: (B)(6) (B)(6)2024 NOT DETECTED (B)(6) (B)(6)2024 HPV 18 SAMPLE ID: TEST DATE: ALINITY M HR HPV TEST RESULT: (B)(6) (B)(6)2024 NOT DETECTED (B)(6) (B)(6)2024 HPV 16 SAMPLE ID: TEST DATE: ALINITY M HR HPV TEST RESULT: (B)(6) (B)(6)2024 NOT DETECTED (B)(6) (B)(6)2024 OTHER HR HPV B SAMPLE ID: TEST DATE: ALINITY M HR HPV TEST RESULT: (B)(6) (B)(6)2024 NOT DETECTED (B)(6) (B)(6)2024 OTHER HR HPV B SAMPLE ID: TEST DATE: ALINITY M HR HPV TEST RESULT: (B)(6) (B)(6)2024 NOT DETECTED (B)(6) (B)(6)2024 OTHER HR HPV B SAMPLE ID: TEST DATE: ALINITY M HR HPV TEST RESULT: (B)(6) (B)(6)2024 NOT DETECTED (B)(6) (B)(6)2024 HPV 16 SAMPLE ID: TEST DATE: ALINITY M HR HPV TEST RESULT: (B)(6) (B)(6)2024 NOT DETECTED (B)(6) (B)(6)2024 OTHER HR HPV B SAMPLE ID: TEST DATE: ALINITY M HR HPV TEST RESULT: (B)(6) (B)(6)2024 NOT DETECTED (B)(6) (B)(6)2024 OTHER HR HPV B SAMPLE ID: TEST DATE: ALINITY M HR HPV TEST RESULT: (B)(6) (B)(6)2024 NOT DETECTED (B)(6) (B)(6)2024 HPV 16 SAMPLE ID TEST DATE ALINITY M HR HPV TEST RESULT (B)(6) (B)(6)2024 NOT DETECTED (B)(6) (B)(6)2024 OTHER HR HPV A SAMPLE ID: TEST DATE: ALINITY M HR HPV TEST RESULT: (B)(6) (B)(6)2024 NOT DETECTED (B)(6) (B)(6)2024 OTHER HR HPV A SAMPLE ID: TEST DATE: ALINITY M HR HPV TEST RESULT: (B)(6) (B)(6)2024 NOT DETECTED. (B)(6) (B)(6)2024 HPV 16. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297623 ALINITY M HR HPV AMP KIT KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS MAQ ABBOTT MOLECULAR, INC. 399449 00884999047921

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown