BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLP CENTRIFUGE MODULE

    MDR report key: 22476316 · Received July 10, 2025

    Report

    Report Number
    3023268435-2025-00010
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Date of Event
    June 30, 2025
    Report Date
    August 22, 2025
    Manufacturer
    ABBOTT AUTOMATION SOLUTIONS GMBH
    Product Code
    JQP
    UDI-DI
    00380740186647
    PMA / PMN Number
    K213486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 06Q03 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 04Z96, WITH 510K NUMBER K213486.

    Additional Manufacturer Narrative · 0

    THE GLP CENTRIFUGE MODULE (CM) SERIAL (B)(6) WAS EVALUATED. PRINTED CIRCUIT BOARD (PCB) ROBOT DISTRIBUTION 5 WAS FOUND TO HAVE ELECTRICAL DAMAGE ISOLATED TO A SINGLE ELECTRICAL COMPONENT. PCB ROBOT DISTRIBUTION 5 WAS REPLACED, WHICH RESOLVED THE CUSTOMER REPORTED EVENT. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY OTHER COMPLAINTS FOR THE GLP CENTRIFUGE MODULE (CM) OR THE PCB ROBOT DISTRIBUTION 5 WITH REGARDS TO THE CUSTOMER REPORTED EVENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES AS IT RELATES TO THE CUSTOMER REPORTED EVENT. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED ISSUE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE GLP CENTRIFUGE MODULE (CM) SERIAL (B)(6) AND PRINTED CIRCUIT BOARD (PCB) ROBOT DISTRIBUTION 5.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE GLP CENTRIFUGE MODULE HAD A GRIPPER ROBOT ROTATOR ERROR. UPON FURTHER ASSESSMENT, IT WAS NOTED THAT THERE WAS BURNING ON A PRINTED CIRCUIT BOARD (PCB). THERE WAS NO IMPACT TO USER SAFETY AND THERE WAS NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE GLP CENTRIFUGE MODULE HAD A GRIPPER ROBOT ROTATOR ERROR. UPON FURTHER ASSESSMENT, IT WAS NOTED THAT THERE WAS BURNING ON A PRINTED CIRCUIT BOARD (PCB). THERE WAS NO IMPACT TO USER SAFETY AND THERE WAS NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948467 GLP CENTRIFUGE MODULE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT AUTOMATION SOLUTIONS GMBH 00380740186647

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown