BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLP CENTRIFUGE MODULE

    MDR report key: 21028569 · Received December 27, 2024

    Report

    Report Number
    3023268435-2024-00021
    Event Type
    Malfunction
    Date Received
    December 27, 2024
    Date of Event
    December 10, 2024
    Report Date
    January 20, 2025
    Manufacturer
    ABBOTT AUTOMATION SOLUTIONS GMBH
    Product Code
    JQP
    UDI-DI
    00380740208691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLETE ENTRY FOR SECTION E1 - PHONE NUMBER: (B)(6). 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

    UPDATE TO SECTION H6 - ADVERSE EVENT PROBLEM, INVESTIGATION CONCLUSIONS THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, PRODUCT NAME (EX. GLP CENTRIFUGE MODULE), LIST NUMBER 06Q03, WHICH HAS A SAME/SIMILAR COMPONENT OF THE MODULAR GLP TRACK SYSTEM REGISTERED IN THE US, LIST NUMBER 04Z96-51, 510K K213486. THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED GLP CENTRIFUGE MODULE (CM), SERIAL (B)(6) AND DETERMINED THAT THERE WAS DAMAGE TO THE GLP CENTRIFUGE MAIN CONTROL BOARD AND A CABLE. THE FSR REPLACED THE CENTRIFUGE, WHICH RESOLVED THE ISSUE. A REVIEW OF TRACKING AND TRENDING OF THE GLP CENTRIFUGE DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. THE 2024 UL CERTIFICATION MEMO INDICATES THAT ABBOTT DIAGNOSTIC EQUIPMENT AND ACCESSORIES ARE CERTIFIED TO THE APPROPRIATE SAFETY STANDARDS, AND ADEQUATE PROTECTION IS PROVIDED FOR THE OPERATOR AGAINST SPREAD OF FIRE FROM THE EQUIPMENT. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE GLP CENTRIFUGE MODULE (CM), SERIAL (B)(6) AND GLP CENTRIFUGE WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE FIELD SERVICE ENGINEER OBSERVED CHARRED CABLES AND BURN DAMAGE ON THE MAIN CONTROL BOARD OF THE GLP CENTRIFUGE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT AND NO HARM TO THE USER REPORTED.

    Description of Event or Problem · 0

    THE FIELD SERVICE ENGINEER OBSERVED CHARRED CABLES AND BURN DAMAGE ON THE MAIN CONTROL BOARD OF THE GLP CENTRIFUGE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT AND NO HARM TO THE USER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813454 GLP CENTRIFUGE MODULE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT AUTOMATION SOLUTIONS GMBH 00380740208691

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GLP CENTRIFUGE, 06Q04-51, (B)(4).| GLP CENTRIFUGE, 06Q04-51, (B)(4).