BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLP CENTRIFUGE MODULE

    MDR report key: 22294119 · Received June 19, 2025

    Report

    Report Number
    3023268435-2025-00009
    Event Type
    Malfunction
    Date Received
    June 19, 2025
    Date of Event
    May 27, 2025
    Report Date
    July 10, 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
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 06Q03-01 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4Z96, WITH 510K/PMA/BLA NUMBER K213486. SECTION A PATIENT INFORMATION: THIS REPORT INVOLVES THE EMPLOYEE OPERATOR, NOT A PATIENT. NO ADDITIONAL OPERATOR INFORMATION PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A.3 GENDER - GENDER OF OPERATOR OF DEVICE REPORTED AS FEMALE. THE FIELD SERVICE REPRESENTATIVE (FSR) TROUBLESHOOTED THE ISSUE AND INSTRUCTED THE CUSTOMER ON HOW TO PROPERLY LOCK THE CENTRIFUGE COVER AND REPLACED AND TIGHTENED THE MISSING SCREW. ADDITIONALLY, ABBOTT AUTOMATION SOLUTIONS (AAS) PERFORMED AN INVESTIGATION AND DETERMINED THERE WERE TWO DIFFERENT ISSUES INVOLVED WITH THE CM. THE ISSUE REGARDING THE MISSING SCREW SHOWED THAT THE LOCATION WAS AT THE HOOD REAR SCREW AND COULD NOT CONFIRM IF THE SCREW WAS NOT INSTALLED DURING MANUFACTURING OR AT THE CUSTOMER SITE. THE NEW SCREW RESOLVED THE ISSUE. THE SECOND ISSUE INVOLVING THE LOCK FAILURE WAS FOUND TO BE AN OPERATOR ERROR WHERE THE LOCK WAS NOT CLOSED PROPERLY, PROMPTING THE MESSAGE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE INSTRUMENT SERVICE HISTORY REVIEW FOR LIST NUMBER 06Q03-01 REVEALED NO ADDITIONAL SERVICE TICKETS ASSOCIATED WITH THE REPORTED EVENT. THIS IS THE SOLE COMPLAINT OVER THE REFERENCED REVIEW PERIOD. A REVIEW OF TRACKING AND TRENDING FOR THE GLP CENTRIFUGE MODULE (CM) DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. 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 MODULE (CM) FOR SERIAL (B)(6) WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER STATED A SCREW WAS MISSING FROM THE BACK TOP COVER OF THE GLP CENTRIFUGE MODULE, WHICH CAUSED THE LID TO NOT STAY IN PLACE WHEN THEY LIFT THE LID. ONE EMPLOYEE ALMOST HAD THE COVER FALL DOWN ON HEAD. NO INJURY WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER STATED A SCREW WAS MISSING FROM THE BACK TOP COVER OF THE GLP CENTRIFUGE MODULE, WHICH CAUSED THE LID TO NOT STAY IN PLACE WHEN THEY LIFT THE LID. ONE EMPLOYEE ALMOST HAD THE COVER FALL DOWN ON HEAD. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724570 GLP CENTRIFUGE MODULE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT AUTOMATION SOLUTIONS GMBH 00380740186647

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female