BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLP RECAPPER MODULE SL DOUBLE

    MDR report key: 24151921 · Received January 22, 2026

    Report

    Report Number
    3023268435-2026-00002
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    January 15, 2026
    Report Date
    February 20, 2026
    Manufacturer
    ABBOTT AUTOMATION SOLUTIONS GMBH
    Product Code
    JQP
    UDI-DI
    00380740208721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE REPRESENTATIVE REPORTED VISIBLE SMOKE FROM A GLP RECAPPER DOUBLE SL SUPPLY UNIT (PN G 41731 01) AFTER INSTALLING THE ELECTRICAL FEED ADAPTER (PODIS) TO THE GLP TRACK. THE TRACK SECTION WAS SWITCHED OFF, AND NO FIRE OCCURRED. A REPLACEMENT SUPPLY UNIT WAS ORDERED TO RESOLVE THE ISSUE. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS. A REVIEW OF MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND ADEQUATELY PROVIDES FIELD SERVICE THE INSTRUCTIONS TO CORRECTLY INSTALL THE GLP RM TO THE TRACK AND HOW TO REMOVE AND INSTALL THE RM SUPPLY UNIT. IN THIS CASE, THE SUPPLY UNIT WAS RETURNED AND INSPECTED. THE INSPECTION FOUND NO EVIDENCE OF SMOKE RESIDUE; HOWEVER, IT WAS DETERMINED THAT THE INPUT WIRES HAD BEEN INCORRECTLY CONNECTED DURING THE FIELD INSTALLATION. THE LOCAL SERVICE TEAM HAD ALSO REMOVED LABELS AND ADJUSTED THE TERMINALS TO CONFIGURE THE UNIT FOR THE L2 SETUP IN ACCORDANCE WITH THE INSTALLATION MANUAL. BASED ON THE INVESTIGATION, GLP RECAPPER DOUBLE SL, SERIAL NUMBER (B)(6) AND MODULE SUPPLY UNIT 2U (PN G-41731-01) ARE PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, GLP RECAPPER MODULE, LIST NUMBER 06Q09-91, WHICH HAS A SAME/SIMILAR US LIST NUMBER 4Z96, WITH 510K/PMA/BLA NUMBER K213486. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. E1 PHONE NUMBER: COMPLETE PHONE NUMBER IS (B)(6).

    Description of Event or Problem · 0

    ABBOTT FIELD SERVICE ENGINEER (FSE) WAS INSTALLING THE GLP RECAPPER MODULE S DOUBLE ON THE GLP TRACK ((B)(6)), SMOKE AS VISIBLE COMING FROM THE SUPPLY UNIT WHEN CONNECTING THE POWER PLUG OF THE RECAPPER MODULE. THERE WAS NO FIRE, AND AFTER A SHORT TIME AND SWITCHING OFF THE GLP TRACK SECTION, THE SMOKE WAS NO LONGER VISIBLE. ALL MODULES, POWER SUPPLY DISTRIBUTION, AND ACTIVE ELEMENTS ON THIS SECTION OF THE TRACK WERE POWERED ON. THE SMOKE APPEARED WHEN THE RECAPPER MODULE WAS CONNECTED AND THE POWER WAS SWITCHED ON. NO ALARM SYSTEMS WERE TRIGGERED. THERE WERE NO HARM OR INJURIES REPORTED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY REPORTED.

    Description of Event or Problem · 0

    ABBOTT FIELD SERVICE ENGINEER (FSE) WAS INSTALLING THE GLP RECAPPER MODULE S DOUBLE ON THE GLP TRACK (AAS660), SMOKE AS VISIBLE COMING FROM THE SUPPLY UNIT WHEN CONNECTING THE POWER PLUG OF THE RECAPPER MODULE. THERE WAS NO FIRE, AND AFTER A SHORT TIME AND SWITCHING OFF THE GLP TRACK SECTION, THE SMOKE WAS NO LONGER VISIBLE. ALL MODULES, POWER SUPPLY DISTRIBUTION, AND ACTIVE ELEMENTS ON THIS SECTION OF THE TRACK WERE POWERED ON. THE SMOKE APPEARED WHEN THE RECAPPER MODULE WAS CONNECTED AND THE POWER WAS SWITCHED ON. NO ALARM SYSTEMS WERE TRIGGERED. THERE WERE NO HARM OR INJURIES REPORTED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281202 GLP RECAPPER MODULE SL DOUBLE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT AUTOMATION SOLUTIONS GMBH 00380740208721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown