BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLP TRACK END

    MDR report key: 25207018 · Received May 18, 2026

    Report

    Report Number
    3023268435-2026-00007
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    May 1, 2026
    Report Date
    May 18, 2026
    Manufacturer
    ABBOTT AUTOMATION SOLUTIONS GMBH
    Product Code
    JQP
    UDI-DI
    00380740196950
    PMA / PMN Number
    K213486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. THIS REPORT IS BEING FILED ON GLP TRACK END, LIST NUMBER 06Q42-51, WHICH IS A COMPONENT OF THE MODULAR GLP TRACK SYSTEM REGISTERED IN THE US, LIST NUMBER 04Z96-51, 510K K213486.

    Description of Event or Problem · 0

    THE FIELD SERVICE ENGINEER (FSE) REPORTED SMOKE COMING FROM THE GLP TRACK END. THE FSE STATED THAT WHEN THE POWER WAS TURNED ON, SMOKE WAS COMING FROM THE 5V BOX. THE POWER WAS IMMEDIATELY SHUT OFF. THE ELECTRICIANS PERFORMED AN INSPECTION OF THE INPUT POWER AND IDENTIFIED AN ISSUE WITH THE UPS/TRANSFORMER UNIT. THE GROUND WAS INCORRECTLY WIRED, AND VOLTAGE WAS IMPROPERLY PRESENT ON THE NEUTRAL LINE. THE WIRING WAS CORRECTED TO ESTABLISH PROPER LINE, NEUTRAL, AND GROUND CONFIGURATION, INCLUDING INSTALLATION OF THE REQUIRED BONDED NEUTRAL. POWER WAS THEN RESTORED TO THE SYSTEM, AND NO FURTHER ISSUES WERE OBSERVED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT, USER SAFETY, OR FACILITY DAMAGE REPORTED. NO INJURIES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528525 GLP TRACK END CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT AUTOMATION SOLUTIONS GMBH 00380740196950

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown