BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M HR HPV AMP KIT

    MDR report key: 24561115 · Received March 10, 2026

    Report

    Report Number
    3005248192-2026-00021
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Date of Event
    January 19, 2026
    Report Date
    April 29, 2026
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    MAQ
    UDI-DI
    00884999047921
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS COMPLAINT INCLUDED A FILE SAMPLE EVALUATION, CUSTOMER DATA REVIEW, A QUALITY DATA REVIEW AND A COMPLAINT HISTORY REVIEW. INVESTIGATION IS SUMMARIZED AS FOLLOWS: RETAIN / FILE SAMPLE REVIEW: THE FILE SAMPLE EVALUATION FOR ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOTS 417268 AND 415953 WAS PERFORMED AND ALL TESTING MET THE ACCEPTANCE CRITERIA WITH A PASS DISPOSITION. THE ASSAY MET SPECIFICATION REQUIREMENTS, AND NO ERROR CODES OR FLAGS WERE DISPLAYED FOR THE RUN CONTROLS. THERE WERE NO INSTANCES OF FALSE NEGATIVE RESULTS. THE FILE SAMPLE EVALUATION TESTING RESULTS DID NOT VERIFY CUSTOMER'S OBSERVATION. CUSTOMER DATA REVIEW: ALL RELEVANT 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. THE AMPLIFICATION CURVES OF EACH REPORTED SAMPLE WERE REVIEWED, AND THE CURVES WERE NORMAL IN BOTH BASELINE AND RAW DATA. THE REPORTED TESTS EXHIBITED NEGATIVE RESULTS, AS NO FRACTIONAL CYCLE NUMBER (FCN) WAS REPORTED AND THE MAX RATIO FOR HPV45 WAS BELOW THE THRESHOLD. PER THE TICKET TEXT, BOTH THE BIOPSY AND FROTTIS SAMPLES WERE SENT TO THE NATIONAL REFERENCE CENTER, WHERE THEY WERE TESTED FOR HPV ON A DIFFERENT PLATFORM THAT USES DIFFERENT TARGETS TO THOSE OF THE ALINITY M ASSAY. QUALITY DATA REVIEW: CAPA / NON-CONFORMANCE REVIEW: A LOT SPECIFIC CAPA SEARCH WAS PERFORMED TO IDENTIFY ANY EXISTING INTERNAL QUALITY RECORDS THAT COULD RESULT IN THE REPORTED COMPLAINT. DURING PRODUCTION OR INTERNAL USE. KIT LOT 417268 AND 415953 AND COMPONENTS LOTS WERE SEARCHED. THE CAPA REVIEW DID NOT IDENTIFY ANY QUALITY RECORDS RELATED TO THE REPORTED COMPLAINT FOR THE REPORTED LOTS 417268 AND 415953 AND COMPONENT LOTS. BATCH RECORD REVIEW: MANUFACTURING QUALITY ASSURANCE (MQA) REVIEWED THE BATCH RECORD OF ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT NUMBERS 417268 AND 415953 AT THE TIME OF RELEASE AND RECEIVED A DISPOSITION OF "A" (APPROVED). COMPLAINT HISTORY REVIEW: A LOT SPECIFIC COMPLAINT HISTORY REVIEW WAS PERFORMED TO IDENTIFY ANY SIMILAR COMPLAINTS TO THE TICKET BEING INVESTIGATED, WHICH REPORTED DISCREPANT FALSE NEGATIVE RESULTS WHILE USING ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT NUMBERS 417268 AND 415953. THE LOT SPECIFIC COMPLAINT HISTORY REVIEW DID NOT IDENTIFY ANY ADDITIONAL ELEVATED COMPLAINT TICKETS RELATED TO THE REPORTED ISSUE FOR ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT NUMBERS 417268 AND 415953. COMPLAINT TRENDING WAS COMPLETED. A TREND VIOLATION WAS NOT IDENTIFIED AND THE UPPER CONTROL LIMIT (UCL) WAS NOT EXCEEDED FOR BASE LIST PART NUMBER 09N15. NO ADVERSE TREND WAS IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOTS 417268 AND 415953 WAS NOT IDENTIFIED.

    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 MDR SUBMITTED: 3005248192-2026-00022.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT FOR THE HPV45 TARGET ON THE ALINITY M HIGH RISK (HR) HPV AMP KIT. THE TECHNICAL APPLICATION SPECIALIST (TAS) COLLECTED FILES VIA ABBOTTLINK AND INFORMATION FROM THE CUSTOMER. THE PATIENT HAS A CERVICAL MASS PRESENT, AND ON (B)(6) 2026, A BIOPSY WAS TAKEN FOR ANALYSIS, IN WHICH THE LESION LOOKED LIKE A POTENTIAL EPIDERMAL CARCINOMA ASSOCIATED TO HPV. FROTTIS WAS ORDERED ON THE SAME DAY, WITH THINPREP COLLECTION DEVICE. THIS THINPREP WAS TESTED ON ALINITY M ON (B)(6) 2026 WITH SAMPLE ID (SID) (B)(6), WITH A RESULT OF "HPV NOT DETECTED". THE TEST WAS REPEATED ON THE SAME SAMPLE ON (B)(6) 2026, UNDER SID (B)(6), WITH AGAIN THE SAME "HPV NOT DETECTED" RESULTS. BOTH THE BIOPSY AND FROTTIS SAMPLES WERE SENT TO THE NATIONAL REFERENCE CENTER, WHERE THEY WERE TESTED FOR HPV ON A DIFFERENT PLATFORM WHICH USES DIFFERENT TARGETS TO THOSE OF THE ALINITY M ASSAY. IN THESE TESTS, THE BIOPSY SCORED 47661 "COPIES/CELL" FOR THE HPV45 E6 GENE TARGET, WHILE THE THINPREP SAMPLE SCORED >99999 (BEYOND QUANTIFICATION LIMIT) "COPIES/CELL" FOR THE SAME HPV45 E6 TARGET, INDICATING THAT THE SAMPLE IS POSITIVE FOR HPV45. THE HPV45 CURVES IN ALINITY FOR THE AFOREMENTIONED SIDS ARE COMPLETELY FLAT, SHOWING NO AMPLIFICATION OF ANY KIND. THE PATIENT IS A 54 YEAR OLD FEMALE WITH A CERVICAL MASS PRESENT AND SUSPICION OF NEOPLASM. A DETAILED TRANSCRIPT OF THE PATIENT'S BIOPSY HAS BEEN INCLUDED IN THE COMPLAINT. A SUMMARY IS AS FOLLOWS: THE MICROSCOPIC EXAMINATION STRONGLY SUGGESTS A SQUAMOUS CELL CARCINOMA, PRESUMABLY ASSOCIATED WITH HPV. THE IMMUNOPHENOTYPIC PROFILE OF THE LESION IS UNUSUAL; HOWEVER, THE OVERALL APPEARANCE STILL FITS SQUAMOUS CELL CANCER MORE THAN ANY OTHER TYPE. MORE INFORMATION FROM OTHER TESTS OR SURGERY WILL HELP CONFIRM THE FULL PICTURE. THE RESULTS FROM ALINITY HAVE NOT BEEN COMMUNICATED, BUT THE REPORT FROM THE ALTERNATIVE TESTED METHOD AT THE REFERENCE LAB (AML) HAVE BEEN ASSOCIATED TO THE PATIENT HISTORY. THE ASSAY USED BY THE REFERENCE LAB IS AN IN-HOUSE ASSAY, RIATOL HPV GENOTYPING QPCR. THIS ASSAY IS A QUANTITATIVE PCR METHOD TO DETECT 18 INDIVIDUALIZED GENOTYPES OF HPV BY THEIR E6 OR E7 GENE SEQUENCES. THESE TARGETS ARE DIFFERENT FROM THE ONES USED BY ALINITY, AND THE CUSTOMER IS AWARE OF THIS. THERE HAS BEEN NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624239 ALINITY M HR HPV AMP KIT KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS, PRODUCT CODE: MAQ MAQ ABBOTT MOLECULAR, INC. 417268 00884999047921

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female