BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 23242901 · Received October 8, 2025

    Report

    Report Number
    3016438761-2025-00588
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    September 18, 2025
    Report Date
    October 19, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137366
    PMA / PMN Number
    K170317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 MULTIPLE PARTS REPLACEMENT WERE PERFORMED. THERE HAVE BEEN NO FURTHER REPORTS OF DISCREPANT RESULTS SINCE THE FS SITE VISIT WAS CONDUCTED. A REVIEW OF THE ALINITY I SN# (B)(6) 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 NONCONFORMANCES. A REVIEW OF THE ALINITY I IMMUNOASSAY SYSTEMS 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)(6)) ANALYZER.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. SECTION A1 PATIENT IDENTIFIER COMPLETE SID: 250905073401 THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P51-20 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P51-21, WITH 510K/PMA/BLA NUMBER K170317.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE ALINITY I TOTAL B-HCG RESULT ON A PATIENT THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) = 34 / <2 / <2 U/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE ALINITY I TOTAL B-HCG RESULT ON A PATIENT THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) = 34 / <2 / <2 U/L . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2566472 ALINITY I PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I TOTAL BHCG 200T, 07P51-20, 73562UD00| ALNTY I TOTAL BHCG 200T, 07P51-20, 73562UD00