BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M SYSTEM

    MDR report key: 18303183 · Received December 11, 2023

    Report

    Report Number
    3005248192-2023-00308
    Event Type
    Malfunction
    Date Received
    December 11, 2023
    Date of Event
    November 17, 2023
    Report Date
    March 25, 2024
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    OOI
    UDI-DI
    00884999048034
    PMA / PMN Number
    P190025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    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 LIST NUMBER 09N15-090, WHICH IS THE SAME/SIMILAR TO THE ALINITY M HR HPV ASSAY, LIST NUMBER 09N15-095, WHICH RECEIVED FDA APPROVAL. 3005248192-2023-00307, WITH SUSPECT PRODUCT ALINITY M HR HPV AMPLIFICATION REAGENT KIT LIST NUMBER 09N15-090 LOT NUMBER 384923.

    Additional Manufacturer Narrative · 0

    CORRECTED H6. THIS EVENT IS NO LONGER REPORTABLE AGAINST THE ALINITY M SYSTEM, LIST NUMBER 08N53-002. SEE MDR 3005248192-2023-00307 FOR INVESTIGATION OF ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT 384923 FOR THIS INCIDENT.

    Additional Manufacturer Narrative · 0

    LIKELY CAUSE WITHIN THE COMPLAINT TICKET WAS UPDATED FROM ALINITY M SYSTEM, LIST NUMBER 08N53-002 TO ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT 384923 FOR THIS INCIDENT AND WAS NOT INVESTIGATED. SEE MDR 3005248192-2023-00307 FOR INVESTIGATION OF ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT 384923 FOR THIS INCIDENT. INVESTIGATION INTO THIS COMPLAINT INCLUDED A CUSTOMER DATA REVIEW, RETAIN / FILE SAMPLE EVALUATION, 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 AMPLIFICATION CURVES FOR THE REPORTED FALSE NEGATIVE SAMPLES SHOWED NON-SIGMOIDAL AMPLIFICATION. THE FREQUENCY OF OCCURRENCE OF THE ABNORMAL CURVES WAS CALCULATED TO ASSESS THE PERFORMANCE OF THE PRODUCT IN THE FIELD. A PRODUCT DEFICIENCY COULD NOT BE IDENTIFIED FROM THIS ANALYSIS. ADDITIONALLY, 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. THERE IS NO INDICATION THAT THE ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT 384923 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 384923. 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 WITH NO ERROR CODES PRESENTED, NO INSTANCES OF FALSE NEGATIVES, AND NO SIGNS OF ABNORMAL CURVES. 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 384923 (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 384923 (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 384923. COMPLAINT TRENDING WAS PERFORMED AND DID NOT IDENTIFY A TREND VIOLATION. 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 384923 WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED 3 FALSE NOT DETECTED RESULTS ON THE ALINITY M HR HPV AMP KIT. THE CUSTOMER REPORTED ON (B)(6)2023 ALMOST FLAT HPV CURVES THAT THE CUSTOMER SUSPECTS TO BE POSITIVE. ADDITIONALLY THE CUSTOMER REPORTED NON-SIGMOIDAL CURVES. THE SAMPLE IDS (SIDS) ARE (B)(6), (B)(6)AND (B)(6). ALL SAMPLES HAVE BEEN ANALYZED ON THE ALINITY M INSTRUMENT (08N53-02) WITH SERIAL NUMBER (B)(6). DATA ANALYSIS REVEALED THAT ALL THREE SIDS HAVE NOT BEEN RERUN ON THE SAME INSTRUMENT (AT LEAST NOT UNDER THE SAME SID). THERE HAS BEEN NO REPORT OF IMPACT TO PATIENT MANAGEMENT. RESULTS FOR THE 3 FALSE NOT DETECTED RESULTS ARE: SID (B)(6)REPORTED ON 11/22 AS POSITIVE FOR OTHER HPV A AND OTHER HPV B. SID (B)(6)REPORTED ON 11/20 AS POSITIVE FOR HPV 16 AND OTHER HPV A. SID (B)(6)REPORTED ON 11/20 AS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288729 ALINITY M SYSTEM REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM OOI ABBOTT MOLECULAR, INC. 00884999048034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown