BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLP BULK LOADER MODULE

    MDR report key: 22003896 · Received May 12, 2025

    Report

    Report Number
    3023268435-2025-00007
    Event Type
    Malfunction
    Date Received
    May 12, 2025
    Date of Event
    April 22, 2025
    Report Date
    June 9, 2025
    Manufacturer
    ABBOTT AUTOMATION SOLUTIONS GMBH
    Product Code
    JQP
    UDI-DI
    00380740186630
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLETE ENTRY TO SECTION A1 - PATIENT IDENTIFIER (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 06Q02 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 04Z96, WITH 510K NUMBER K213486. 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.

    Additional Manufacturer Narrative · 0

    THE GLP BULK LOADER MODULE (BLM), SERIAL (B)(6), STOPPED WITHOUT GENERATING ANY ALERTS OR MESSAGES TO NOTIFY THE OPERATOR. THE ABBOTT AUTOMATION SOLUTIONS (AAS) TECHNICAL GROUP PERFORMED AN INVESTIGATION BASED ON THE COMPLAINT INFORMATION. AAS STATED THAT THE SOFTWARE VERSION 2.0.0.12 RELEASE WILL HELP MITIGATE THIS ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF COMPLAINT AND TRENDING DATA FOR THE GLP BULK LOADER MODULE DID NOT FIND ANY OTHER COMPLAINTS RELATED TO THE CURRENT ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE GLP BULK LOADER MODULE FOR SERIAL (B)(6) WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A DELAY IN RESULTS WHEN SAMPLES WERE STUCK IN THE GRIPPER OF THE GLP BULK LOADER MODULE. THE GLP BULK LOADER MODULE STOPPED WITH NO ALERTS; SAMPLES WERE STUCK IN THE GRIPPER AND NO OTHER SAMPLES COULD BE UNLOADED. A TOTAL OF NINE SAMPLES (SIDS (B)(6) WERE DELAYED WITH SPECIMENS REQUIRING REDRAW AS THE SAMPLES HAD EXCEEDED STABILITY FOR POTASSIUM. UPDATE, ADDITIONAL PATIENT INFORMATION WAS ADDED ON 30APR2025. THE BULK LOADER MODULE STOPPED WITHOUT GIVING ANY ALERTS. TWO SAMPLES (SID (B)(6) WERE STUCK IN THE GRIPPER. THE SAMPLES WERE REDRAWN. THERE WAS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A DELAY IN RESULTS WHEN SAMPLES WERE STUCK IN THE GRIPPER OF THE GLP BULK LOADER MODULE. THE GLP BULK LOADER MODULE STOPPED WITH NO ALERTS, SAMPLES WERE STUCK IN THE GRIPPER AND NO OTHER SAMPLES COULD BE UNLOADED. A TOTAL OF NINE SAMPLES (SIDS (B)(6)) WERE DELAYED WITH SPECIMENS REQUIRING REDRAW AS THE SAMPLES HAD EXCEEDED STABILITY FOR POTASSIUM. UPDATE, ADDITIONAL PATIENT INFORMATION WAS ADDED ON 30APR2025. THE BULK LOADER MODULE STOPPED WITHOUT GIVING ANY ALERTS. TWO SAMPLES (SID (B)(6)) WERE STUCK IN THE GRIPPER. THE SAMPLES WERE REDRAWN. THERE WAS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393744 GLP BULK LOADER MODULE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT AUTOMATION SOLUTIONS GMBH 00380740186630

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown