BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M SYSTEM

    MDR report key: 20297747 · Received September 24, 2024

    Report

    Report Number
    3005248192-2024-00152
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    June 12, 2024
    Report Date
    September 24, 2024
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    OOI
    UDI-DI
    00884999048034
    PMA / PMN Number
    P190025
    Removal / Correction Number
    3005248192-09/12/24-003-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL STUDIES CONCLUDED THAT THE SOURCE OF CYCLE NUMBER DELAY CAN BE TRACED TO METAL LEACHING INTO THE LYSIS SOLUTION FROM THE LYSIS TRANSFER PUMP IN THE ALINITY M SYSTEM. IMPACT ON PRODUCT FUNCTIONALITY: BASED ON THE DATA SUMMARIZED IN 616-RISK, A POTENTIAL HAZARD OF DELAY OF RESULTS WAS IDENTIFIED FOR THE SCENARIO IN WHICH METAL LEACHING IN THE LYSIS BUFFER CAN LEAD TO INVALIDATED HPV AND STI POSITIVE ASSAY CONTROLS. WITHOUT VALID CONTROLS, THE CUSTOMER WILL EXPERIENCE A DELAY IN OBTAINING VALID SAMPLE RESULTS UNTIL THE TROUBLESHOOTING IS PERFORMED TO REMOVE THE LEACHED METAL IN THE LYSIS BUFFER ON THE INSTRUMENT. CONCLUSION: BASED ON THE DATA, THE POTENTIAL HAZARD ASSOCIATED WITH THIS ISSUE IS DELAY IN RESULTS FOR THE HR HPV AND STI ASSAYS. THERE IS NO POTENTIAL FOR INCORRECT RESULTS FOR THE HPV OR STI ASSAYS. ON SEPTEMBER 10, 2024, A DECISION WAS MADE TO ISSUE A CUSTOMER LETTER TO NOTIFY CUSTOMERS OF THE REPORTED ISSUE. THIS FIELD ACTION, FA-AM-SEP2024-300 WAS ISSUED ON SEPTEMBER 12, 2024. ADDITIONALLY, THIS ACTION WAS REPORTED PER 21 CFR 806 TO FDA ON SEPTEMBER 17, 2024 AND IS RECOMMENDED TO BE REPORTED AS AN FSCA (FIELD SAFETY CORRECTIVE ACTION). FOR THE ALINITY M HPV ASSAY, COMPLAINTS ASSOCIATED WITH METAL LEACHING CAUSING INVALIDATED HPV POSITIVE ASSAY CONTROLS MAY BE ASSOCIATED WITH AN UNACCEPTABLE DELAY IN RESULTS, WHICH IS ASSOCIATED WITH A MINIMAL SEVERITY. FOR THE ALINITY M STI ASSAY, COMPLAINTS ASSOCIATED WITH MEAL LEACHING CAUSING INVALIDATED STI POSITIVE ASSAY CONTROLS, MAY BE ASSOCIATED WITH AN UNACCEPTABLE DELAY IN RESULTS, WHICH IS ASSOCIATED WITH A MAJOR SEVERITY.

    Description of Event or Problem · 0

    ALINITY M SYSTEM WAS UNDER ABBOTT CONTROL AT AN ABBOTT SITE WHEN IT WAS IDENTIFIED THAT BOTH THE STI AND HPV POSITIVE CONTROLS WERE NOT REACTIVE. ABBOTT HAS IDENTIFIED AN INCREASE OF INCIDENCES REGARDING ERROR CODE (EC) 9198 (POSITIVE CONTROL IS NONREACTIVE) WHILE USING THE ALINITY M HR HPV AMP KIT AND ALINITY M STI AMP KIT. INVALIDATED POSITIVE ASSAY CONTROLS CAN BE TRACED TO IRON LEACHING INTO THE ALINITY M LYSIS SOLUTION FROM THE LYSIS TRANSFER PUMP IN THE ALINITY M SYSTEM. THERE IS A POTENTIAL FOR NON-REACTIVE POSITIVE CONTROLS TO OCCUR WHILE USING ALINITY M HR HPV AND ALINITY M STI AMP KITS. METAL LEACHING IN THE LYSIS BUFFER CAN LEAD TO INVALIDATED HPV AND STI POSITIVE ASSAY CONTROLS. THE INVALIDATED PATIENT SAMPLES WILL NEED TO BE REPROCESSED, RESULTING IN A POSSIBLE DELAY IN RESULT REPORTING. IT HAS BEEN DETERMINED THAT THERE IS NO IMPACT TO RESULTS GENERATED IF VALID CONTROLS ARE OBTAINED. NO OTHER ALINITY M ASSAYS ARE IMPACTED. ON SEPTEMBER 10, 2024, THROUGH THE APPROVAL OF 616-RISK, A DECISION WAS MADE TO ISSUE A CUSTOMER LETTER TO NOTIFY CUSTOMERS OF THE REPORTED ISSUE. THIS FIELD ACTION, FA-AM-SEP2024-300 WAS ISSUED ON SEPTEMBER 12, 2024. FIELD ACTION WAS REPORTED PER 21 CFR 806 TO US FDA VIA 3005248192-09/12/24-003-C ON SEPTEMBER 17, 2024 AND THEREFORE WILL ALSO BE REPORTED UNDER 21 CFR 803. NOTE, NO PATIENT WAS INVOLVED IN THIS EVENT AS EVENT WAS IDENTIFIED UNDER ABBOTT CONTROL, SYSTEM WAS NOT BEING RUN IN A CUSTOMER SETTING OR WITH TEST OF RECORD SAMPLES; THEREFORE, THERE WERE NO PATIENT SAMPLE RUNS IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2239188 ALINITY M SYSTEM REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM OOI ABBOTT MOLECULAR, INC. 00884999048034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown