BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M HR HPV AMP KIT

    MDR report key: 20855707 · Received December 5, 2024

    Report

    Report Number
    3005248192-2024-00212
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    October 7, 2024
    Report Date
    January 16, 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
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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: THE ASSAY MET SPECIFICATION REQUIREMENTS AS NO ERROR CODES OR FLAGS WERE DISPLAYED FOR THE RUN CONTROLS, INDICATING THE REAGENTS ARE PERFORMING PER SPECIFICATION. RETAIN/FILE SAMPLE REVIEW: THE FILE SAMPLE EVALUATION FOR ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT 399449 WAS PERFORMED. THE FILE SAMPLE EVALUATION FOR LOT 399449 MET THE ACCEPTANCE CRITERIA AND VALIDITY CRITERIA THAT WAS ESTABLISHED. AS A RESULT, THE PRODUCT FILE SAMPLE EVALUATION FOR THE ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT 399449 RECEIVED A DISPOSITION OF PASS. THE FILE SAMPLE EVALUATION FOR ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT 400203 WAS PERFORMED. THE FILE SAMPLE EVALUATION MET ALL VALIDITY AND ACCEPTANCE CRITERIA. THE FILE SAMPLE EVALUATION FOR LOT 400203 MET THE ACCEPTANCE CRITERIA AND VALIDITY CRITERIA THAT WAS ESTABLISHED. AS A RESULT, THE PRODUCT FILE SAMPLE EVALUATION FOR THE ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT 400203 RECEIVED A DISPOSITION OF PASS. 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 COMPONENTS) DID NOT IDENTIFY ANY ISSUES THAT COULD RESULT IN THE REPORTED COMPLAINT. NO ISSUES OR RECORDS RELATED TO THE REPORTED COMPLAINT WERE FOUND THAT WOULD INDICATES ANY ISSUES THAT COULD HAVE LED TO THE REPORTED COMPLAINT. THE QUALITY CONTROL (QC) AMP KIT MASTERLOT TESTING FOR ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT 399449 (INCLUDING COMPONENTS) MET ALL VALIDITY AND ACCEPTANCE CRITERIA. NO ISSUES RELATED TO THE REPORTED COMPLAINT WERE FOUND DURING QC TESTING. REVIEW OF THE MANUFACTURING PACKETS FOR ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT 400203 (INCLUDING COMPONENTS) DID NOT IDENTIFY ANY ISSUES THAT COULD RESULT IN THE REPORTED COMPLAINT. NO RECORDS RELATED TO THE REPORTED COMPLAINT WERE FOUND THAT WOULD INDICATES ANY ISSUES THAT COULD HAVE LED TO THE REPORTED COMPLAINT. THE QUALITY CONTROL (QC) AMP KIT MASTERLOT TESTING FOR ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOT 400203 (INCLUDING COMPONENTS) MET ALL VALIDITY AND ACCEPTANCE CRITERIA. NO ISSUES RELATED TO THE REPORTED COMPLAINT WERE FOUND DURING QC TESTING. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED BY THIS REVIEW. CAPA / 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 399449, 399341, 399342, 400203, 400204, AND 400205 WERE SEARCHED. THE CAPA REVIEW DID NOT IDENTIFY ANY EXISTING INTERNAL RECORDS OR NONCONFORMANCES RELATED TO THE REPORTED COMPLAINT FOR LOTS 399449, 399341, 399342, 400203, 400204, AND 400205. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED BY THIS REVIEW. COMPLAINT HISTORY REVIEW: A LOT SPECIFIC COMPLAINT HISTORY REVIEW WAS PERFORMED TO IDENTIFY ANY SIMILAR COMPLAINTS TO THE CASE BEING INVESTIGATED IN (B)(4), WHICH REPORTED DISCREPANT FALSE NEGATIVE RESULTS FOR THE HR HPV GENOTYPE 45 WHILE USING ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOTS 399449 AND 400203. 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 A PRODUCT DEFICIENCY FOR ALINITY M HR HPV AMP KIT (LIST 09N15-090) LOTS 399449 AND 400203 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. AS THE EVENT OCCURRED OVER MULTIPLE LOT NUMBERS, THE FOLLOWING MDR HAS BEEN SUBMITTED WITH THE FOLLOWING LOT NUMBERS: 3005248192-2024-00213, LOT NUMBER: 400203.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT FOR SAMPLE ID (SID) (B)(6) ON THE ALINITY M HR HPV ASSAY ON (B)(6) 2024. THE CUSTOMER RECEIVED SUREPATH SAMPLE TAKEN FROM THE CERVICAL CANAL (SID (B)(6)). THE PATIENT WAS SCHEDULED FOR HR HPV PCR-BASED TESTS ON ALINITY M AND A PARALLEL LIQUID-BASED CYTOLOGY (LBC) TEST. CYTOLOGY REVEALED THE PRESENCE OF KOILOCYTES (HPV-INFECTED CELLS). AS A RESULT, ON (B)(6) 2024 THE PHYSICIAN TOOK A CERVICAL SMEAR SAMPLE (CERVI COLLECT), AND ORDERED EXTENDED HPV GENOTYPING TEST (SID (B)(6)). ON (B)(6) 2024, SID (B)(6) WAS TESTED WITH THE ALLPLEX, AND HPV 28 DETECTION TEST (SEEGENE) ON THE AIOS SEEGENE APPARATUS. SID (B)(6) WAS FOUND TO BE HPV45-POSITIVE. SID (B)(6) WAS TESTED ON ALINITY M HR HPV ASSAY ON (B)(6) 2024 WITH RESULT "NOT DETECTED". ON (B)(6) 2024, BOTH SAMPLES (SIDS (B)(6)) WERE RE-TESTED WITH THE USE OF SEEGENE TEST. BOTH SAMPLES GAVE POSITIVE RESULT FOR HPV 45. SAMPLE SID (B)(6) WAS CONSIDERED EXPIRED AT THIS TIME (MATERIAL AFTER THE STABILITY DATE). IN ORDER TO TROUBLESHOOT FURTHER, THE CUSTOMER PERFORMED HPV PCR-BASED TESTING WITH SACACE TEST WITH THE USE OF ISOLATES FROM (B)(6) 2024 (SID (B)(6)) AND FROM (B)(6) 2024 (SIDS (B)(6)). ALL THREE SAMPLES WERE FOUND TO BE POSITIVE FOR HPV 45. ON (B)(6) 2024, SAMPLES SIDS (B)(6) WERE RE-TESTED ON ALINITY M HR HPV TEST WITH RESULT "NOT DETECTED". THE VISUAL LOGS WERE REVIEWED. EACH RESULT GENERATED WAS A VALID "NOT DETECTED" RESULT. ALL FOUR AFOREMENTIONED RUNS WERE PROCESSED WITHOUT ANY ERRORS. DUE TO PRESENCE OF HPV-INFECTED CELLS IN LBC (LSIL FOR LOW-GRADE SQUAMOUS INTRAEPITHELIAL LESIONS), THE PATIENT WILL BE TREATED FOR HPV ACCORDING TO NATIONAL RULES/REQUIREMENTS. THE PATIENT WILL BE MONITORED FOLLOWED BY RE-TESTING AFTER 12 MONTHS. THE HPV45-POSITIVE RESULT WITH ACCOMPANYING LSIL IS NOT ELIGIBLE FOR COLPOSCOPY OR FOR LARGE LOOP EXCISION OF THE TRANSFORMATION ZONE (LLETZ) TREATMENT, ABLATION, OR OTHERS. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2078969 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