BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLP TRACK END

    MDR report key: 24753895 · Received April 1, 2026

    Report

    Report Number
    3023268435-2026-00004
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 23, 2026
    Report Date
    April 13, 2026
    Manufacturer
    ABBOTT AUTOMATION SOLUTIONS GMBH
    Product Code
    JQP
    UDI-DI
    00380740196950
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) IDENTIFIED THAT DURING INSTALLATION OF GLP TRACK, SERIAL (B)(6), THE ASSOCIATED 5V POWER SUPPLY HAD THE WRONG PHASE BLACK CABLE ATTACHED, CAUSING A SHORT WHERE SMOKE WAS VISIBLE FROM THE UNIT. NO INJURY WAS REPORTED, AND A REPLACEMENT POWER SUPPLY WAS ORDERED TO RESOLVE THE ISSUE. A REVIEW OF TRACKING AND TRENDING OF THE GLP TRACK END DID NOT FIND ANY OTHER COMPLAINTS RELATED TO THE CURRENT ISSUE AND NO TRENDS WERE IDENTIFIED. CURRENT LABELING PROVIDES FIELD SERVICE THE INSTRUCTIONS FOR CONFIGURING AND SETTING UP THE PODIS CONNECTION FOR THE GLP TRACK POWER SUPPLY. BASED ON THE INVESTIGATION THE GLP TRACK, SERIAL (B)(6) PERFORMED AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE GLP TRACK, SERIAL (B)(6) OR THE 5V POWER SUPPLY WAS IDENTIFIED. THIS REPORT IS BEING FILED ON THE GLP TRACK END, LIST NUMBER 06Q42-51, WHICH HAS A SAME/SIMILAR COMPONENT OF THE GLP IN/OUT MODULE (IOM), LIST 4Z96, 510K K213486.

    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.

    Description of Event or Problem · 0

    DURING INSTALLATION OF THE GLP TRACKING END THE TECHNICAL SERVICE SPECIALIST (TSS) OBSERVED SMOKE COMING FROM THE 5V POWER SUPPLY. THIS OCCURRED DURING THE CONNECTING PHASE OF INSTALLING THE POWER SUPPLY AND THE INCORRECT BLACK CABLE WAS MOVED WHICH CAUSED A SHORT CIRCUIT. WHITE SMOKE WAS SEEN COMING OUT OF THE POWER SUPPLY. A NEW POWER SUPPLY WAS ORDERED AND INSTALLED. THERE WAS NO INJURY TO THE TSS OR CUSTOMER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THERE WAS NO INJURY TO THE TSS, OR CUSTOMER REPORTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    DURING INSTALLATION OF THE GLP TRACKING END THE TECHNICAL SERVICE SPECIALIST (TSS) OBSERVED SMOKE COMING FROM THE 5V POWER SUPPLY. THIS OCCURRED DURING THE CONNECTING PHASE OF INSTALLING THE POWER SUPPLY AND THE INCORRECT BLACK CABLE WAS MOVED WHICH CAUSED A SHORT CIRCUIT. WHITE SMOKE WAS SEEN COMING OUT OF THE POWER SUPPLY. A NEW POWER SUPPLY WAS ORDERED AND INSTALLED. THERE WAS NO INJURY TO THE TSS OR CUSTOMER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THERE WAS NO INJURY TO THE TSS, OR CUSTOMER REPORTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814725 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