BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M HR HPV AMP KIT

    MDR report key: 23476515 · Received November 5, 2025

    Report

    Report Number
    3005248192-2025-00462
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    September 22, 2025
    Report Date
    January 2, 2025
    Manufacturer
    ABBOTT MOLECULAR, INC
    Product Code
    MAQ
    UDI-DI
    00884999047921
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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. RELATED MDR FOR ADDITIONAL LOT: 3005248192-2025-00463.

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE SUMMARIZED AS FOLLOWS: RETAIN / FILE SAMPLE EVALUATION: THE FILE SAMPLE EVALUATION WAS PERFORMED. THE FILE SAMPLE EVALUATION FOR ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT 410617 MET ALL ACCEPTANCE CRITERIA AS THE VALIDITY OF THE RUNS MET ALL ASSAY REQUIREMENTS. THERE WERE NO ERROR CODES OR PERFORMANCE RELATED FLAGS EXHIBITED FOR THE RUN CONTROLS. ALL REPLICATES INCLUDED IN THE CALCULATIONS WERE INTERPRETED CORRECTLY. THEREFORE, THE FILE SAMPLE EVALUATION FOR ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT 410617 RECEIVED DISPOSITIONS OF PASS. CUSTOMER DATA REVIEW: THE CUSTOMER DATA WAS REVIEWED. THE ASSAY MET SPECIFICATION REQUIREMENTS AS NO ERROR CODES OR FLAGS WERE DISPLAYED FOR THE AVAILABLE QUALITY CONTROL (QC) DATA, INDICATING THE REAGENTS ARE PERFORMING PER SPECIFICATION. AS WITH ANY DIAGNOSTIC TEST, THE RESULTS FROM THE ALINITY M HR HPV ASSAY SHOULD BE INTERPRETED IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS. IF THE HPV RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT. QUALITY DATA REVIEW: DEVICE HISTORY REVIEW (DHR): THE MANUFACTURING PACKET FOR ALINITY M HR HPV AMP KIT (LIST 09N15-90) LOT 410617 WAS REVIEWED TO IDENTIFY IF THERE WERE ANY ISSUES RELATED TO THE REPORTED COMPLAINT. NO ISSUES WERE IDENTIFIED WHICH COULD RESULT IN THE REPORTED COMPLAINT. THE QUALITY CONTROL (QC) CONTROL KIT MASTERLOT TESTING FOR ALINITY M HR HPV AMP KIT (LIST 09N15-90) LOT 410617 (INCLUDING COMPONENTS) MET ALL VALIDITY AND ACCEPTANCE CRITERIA. NO ISSUES RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED DURING QC TESTING. CAPA (CORRECTIVE AND PREVENTIVE ACTION) / NON-CONFORMANCE REVIEW: A LOT SPECIFIC CAPA SEARCH WAS PERFORMED TO IDENTIFY RELATED EXISTING INTERNAL QUALITY RECORDS TO THE REPORTED COMPLAINT DURING PRODUCTION OR INTERNAL USE. LOTS 410617, 410618, AND 410619 WERE SEARCHED. THE LOT SPECIFIC CAPA REVIEW DID NOT IDENTIFY ANY EXISTING INTERNAL RECORDS OR NONCONFORMANCES RELATED TO THE REPORTED COMPLAINT FOR LOTS 410617, 410618, AND 410619. COMPLAINT HISTORY REVIEW: A LOT SPECIFIC COMPLAINT HISTORY REVIEW WAS PERFORMED TO IDENTIFY ANY SIMILAR ELEVATED COMPLAINTS TO THE CASE BEING INVESTIGATED, WHICH REPORTED DISCREPANT FALSE NEGATIVE RESULTS WHILE USING ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT 410617. THE COMPLAINT HISTORY REVIEW DID NOT IDENTIFY ANY ADDITIONAL ELEVATED COMPLAINTS RELATED TO THE REPORTED ISSUE FOR ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT 410617. COMPLAINT TRENDING WAS COMPLETED. A TREND VIOLATION WAS NOT IDENTIFIED AS THE UPPER CONTROL LIMIT WAS NOT EXCEEDED FOR PRODUCT 9N15 (BASE LIST PART NUMBER). NO ADVERSE TREND WAS IDENTIFIED IN THIS DATASET. BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT 410617 WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED DISCREPANT FALSE NEGATIVE RESULTS ON ALINITY M HR HPV ASSAY. SAMPLE ID (SID) (B)(6) WAS PROCESSED ON (B)(6) 2025 WITH RESULT "HPV16 DETECTED" (FRACTIONAL CYCLE NUMBER (FCN) OF 30.63 WITH MR OF 0.11). THE SAMPLE WAS RE-PROCESSED ON (B)(6) 2025 WITH RESULT "NOT DETECTED". SID (B)(6) WAS PROCESSED ON (B)(6) 2025 WITH RESULT "HPV16 DETECTED" (FCN OF 30.95 WITH MR OF 0.15). THE SAMPLE WAS RE-PROCESSED ON (B)(6) 2025 WITH RESULT "NOT DETECTED". SID (B)(6) WAS PROCESSED ON 1 OCT. 2025 WITH RESULT "HPV16 DETECTED" (FCN OF 30.05 WITH MR OF 0.24). THE SAMPLE WAS RE-PROCESSED ON (B)(6) 2025 WITH RESULT "NOT DETECTED" (C560 FCN OF 34.07 WITH MR OF 0.14). VISUAL CURVE INSPECTION SHOWED AMPLIFICATION OF HPV16 TARGET. SID (B)(6) WAS PROCESSED ON (B)(6) 2025 WITH RESULT "HPV16 DETECTED" (FCN OF 30.74 WITH MR OF 0.11). THE SAMPLE WAS RE-PROCESSED ON (B)(6) 2025 WITH RESULT "NOT DETECTED". SID (B)(6) WAS PROCESSED ON (B)(6) 2025 WITH RESULT "HPV16 DETECTED" (FCN OF 30.08 WITH MR OF 0.23). THE SAMPLE WAS RE-PROCESSED ON (B)(6) 2025 WITH RESULT "NOT DETECTED". SIDS (B)(6) , (B)(6) , (B)(6) , (B)(6) , (B)(6) , AND (B)(6) WERE RELEASED FROM THE LABORATORY AS "DETECTED". THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2636380 ALINITY M HR HPV AMP KIT KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS MAQ ABBOTT MOLECULAR, INC 410617 00884999047921

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown