BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 13471941 · Received February 7, 2022

    Report

    Report Number
    3016438761-2022-00056
    Event Type
    Malfunction
    Date Received
    February 7, 2022
    Date of Event
    December 8, 2021
    Report Date
    February 7, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137366
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FIELD SERVICE (FS) INVESTIGATED THE ISSUE ON SITE. THE ANALYZER WAS INSPECTED, AND VARIOUS DIAGNOSTIC CHECKS OF THE SYSTEM AND CLEANING OF THE BUFFER DISTRIBUTION MANIFOLD WERE PERFORMED, WHICH WAS DETERMINED TO BE THE LIKELY CAUSE. THERE HAVE BEEN NO FURTHER REPORTS OF DISCREPANT RESULTS SINCE THE FS SITE VISIT WAS CONDUCTED. A REVIEW OF THE ALINITY I SN# (B)(4) SERVICE HISTORY WAS NOT ABLE TO IDENTIFY OR CONFIRM ANY ADDITIONAL LIKELY CAUSES. A REVIEW OF HISTORICAL DATA REVEALED NO TRENDS, SYSTEMIC ISSUES, OR RELATED NON-CONFORMANCES. A REVIEW OF THE ALINITY I / CLINICAL CHEMISTRY SYSTEMS REVEALED FOUND NO SYSTEMIC ISSUES OR TRENDS FOR THE ISSUE ASSOCIATED WITH THIS TICKET (ERRATIC/DISCREPANT RESULTS). MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF LABELLING ADEQUATELY ADDRESSES SAMPLE RESULTS OBSERVED PROBLEMS FOR ERRATIC / DISCREPANT RESULTS. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I (SN# (B)(4) ANALYZER. THE INITIAL REPORT WAS SUBMITTED UNDER MANUFACTURER REPORT NUMBERS 3005094123-2022-00006-00 (B)(4) AS MANUFACTURING SITE) WITH SUSPECT MEDICAL DEVICE OF ALINITY I TOTAL B-HCG REAGENT KIT, LIST 7P51. AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED TO ALINITY I, LIST 3R65 (IRVING, TX AS MANUFACTURING SITE), WHICH IS THIS REPORT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE ALINITY I TOTAL B-HCG RESULT ON A PATIENT. RESULTS PROVIDED: (B)(6) 2021 = 43 / < 2.3 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975619 ALINITY I PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 03R6501 00380740137366

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALIN I BHCG 200T (CN), 07P51-74, 28420UD02