BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLP CENTRIFUGE MODULE

    MDR report key: 21922362 · Received April 28, 2025

    Report

    Report Number
    3023268435-2025-00005
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Date of Event
    April 8, 2025
    Report Date
    June 9, 2025
    Manufacturer
    ABBOTT AUTOMATION SOLUTIONS GMBH
    Product Code
    JQP
    UDI-DI
    00380740208691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.THIS REPORT IS BEING FILED ON, GLP CENTRIFUGE MODULE, LIST NUMBER 06Q03-51, WHICH HAS A SAME/SIMILAR COMPONENT OF THE MODULAR GLP TRACK SYSTEM REGISTERED IN THE US, LIST NUMBER 04Z96, 510K K213486.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED AND WAS ABLE TO PLACE THE CENTRIFUGE BACK ONTO THE RAILS IN THE CENTRIFUGE MODULE, RESOLVING THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TRACKING AND TRENDING FOR THE GLP CENTRIFUGE DID NOT FIND ANY OTHER COMPLAINTS RELATED TO THE CURRENT ISSUE. NO ADVERSE TREND WAS IDENTIFIED. THIS IS THE SOLE COMPLAINT OVER THE REFERENCED REVIEW PERIOD. REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE GLP CENTRIFUGE FOR SERIAL M20A010007 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED THAT THEY HAD TO PULL THE GLP CENTRIFUGE OUT TO RETRIEVE A SAMPLE DUE TO AN ERROR. WHEN TRYING TO PUSH THE CENTRIFUGE BACK IN, IT WAS NOTED TO BE FALLING OFF THE TRACK/DRAWER, AND TOO HEAVY TO TRY AND PUT BACK ON. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO IMPACT OR NEGATIVE IMPACT TO THE USER OCCURRED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED THAT THEY HAD TO PULL THE GLP CENTRIFUGE OUT TO RETRIEVE A SAMPLE DUE TO AN ERROR. WHEN TRYING TO PUSH THE CENTRIFUGE BACK IN, IT WAS NOTED TO BE FALLING OFF THE TRACK/DRAWER, AND TOO HEAVY TO TRY AND PUT BACK ON. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO IMPACT OR NEGATIVE IMPACT TO THE USER OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1756065 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, M20A010007| GLP CENTRIFUGE, 06Q04-51, M20A010007