BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 24714961 · Received March 30, 2026

    Report

    Report Number
    3016438761-2026-00176
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 7, 2026
    Report Date
    April 16, 2026
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137366
    PMA / PMN Number
    K170317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULT FOR AN 83-YEAR-OLD FEMALE PATIENT. THE PHYSICIAN QUESTIONED THE INITIAL RESULT BECAUSE A SUBSEQUENT SAMPLE PRODUCED A NORMAL VALUE. THE FOLLOWING DATA WERE PROVIDED: NORMAL RANGE FOR FEMALE: <14 NG/L SID (B)(6) (INITIAL DRAW): (B)(6) 2026 @ 12:44 RESULT = 37.380 NG/L REPEAT RESULT (POST RESPUN) = 7.502 NG/L SID (B)(6) (SECOND DRAW): (B)(6) 2026 @ 04:03 RESULT = 6.952 NG/L REPEAT RESULT (POST RESPUN) = 8.261 NG/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407240 ALINITY I PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137366

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female ALIN I HS TNI 200T US, 04Z21-25, 82214UD00