BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M HR HPV AMP KIT

    MDR report key: 18777598 · Received February 26, 2024

    Report

    Report Number
    3005248192-2024-00053
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    February 16, 2024
    Report Date
    April 23, 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
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED G4 FROM P230003 TO N/A AS THIS IS A A SAME/SIMILAR REPORT AGAINST AN INTERNATIONAL LIST NUMBER WITH NO US DISTRIBUTION. 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 RESULT LOG FILES WERE REVIEWED. THE RUNS WERE VALID. THE ASSAY MET SPECIFICATION REQUIREMENTS AS NO ERROR CODES OR FLAGS WERE DISPLAYED FOR THE RUN CONTROLS. THE AMPLIFICATION CURVES APPEARED NORMAL. 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 394665 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. ALL SAMPLE TYPES TESTED GENERATED CORRECT RESULTS (NEGATIVE SAMPLES/CONTROLS WERE NOT DETECTED, AND POSITIVE SAMPLES/CONTROLS GENERATED EXPECTED CALLS). A PRODUCT DEFICIENCY COULD NOT BE IDENTIFIED BY THE FILE SAMPLE EVALUATION FOR THE ALINITY M HR HPV ASSAY (LIST 09N15-090) LOT 394665. 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 394665 (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 394665 (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 394665. 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 394665 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 LIST NUMBER 09N15-090, WHICH IS THE SAME/SIMILAR TO THE ALINITY M HR HPV ASSAY, LIST NUMBER 09N15-095, WHICH RECEIVED FDA APPROVAL.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 2 FALSE NOT DETECTED RESULT WHILE USING THE ALINITY M HIGH RISK (HR) HPV ASSAY. THE CUSTOMER REPORTED THAT SAMPLE ID (SID) (B)(6) WAS FIRST TESTED ON (B)(6) 2024 AND THE RESULT WAS "NOT DETECTED." A VISUAL AMPLIFICATION CURVE INSPECTION SHOWED A RISING SIGNAL FOR THE "HPV 16" TARGET. THE SAMPLE WAS RETESTED ON (B)(6) 2024 AND THE RESULT WAS "HR HPV DETECTED; HPV 16". EACH TEST WAS PERFORMED ON A SAMPLE THAT WAS FRESHLY ALIQUOTED FROM THE MASTER SAMPLE. THE RESULT FOR SID (B)(6) WAS RELEASED FROM THE LABORATORY ON (B)(6) 2024 AS "HPV 16" POSITIVE. SID (B)(6) WAS FIRST TESTED ON (B)(6) 2024 AND THE RESULT WAS "NOT DETECTED." A VISUAL AMPLIFICATION CURVE INSPECTION SHOWED A RISING SIGNAL FOR THE "HPV 16" TARGET. THE SAMPLE WAS RETESTED ON (B)(6) 2024 AND THE RESULT WAS "HR HPV DETECTED; HPV 16". EACH TEST WAS PERFORMED ON A SAMPLE THAT WAS FRESHLY ALIQUOTED FROM THE MASTER SAMPLE. THE RESULT FOR SID (B)(6) WAS RELEASED FROM THE LABORATORY ON (B)(6) 2024 AS "HPV 16" POSITIVE. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323480 ALINITY M HR HPV AMP KIT KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS MAQ ABBOTT MOLECULAR, INC. 394665 00884999047921

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown