BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLP LOADER MODULE

    MDR report key: 21961052 · Received May 5, 2025

    Report

    Report Number
    3023268435-2025-00006
    Event Type
    Injury
    Date Received
    May 5, 2025
    Date of Event
    April 15, 2025
    Report Date
    May 20, 2025
    Manufacturer
    ABBOTT AUTOMATION SOLUTIONS GMBH
    Product Code
    JQP
    UDI-DI
    00380740204143
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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 THE GLP LOADER MODULE, LIST NUMBER 06T12-51, WHICH HAS A SAME/SIMILAR COMPONENT OF THE MODULAR GLP SYSTEMS TRACK REGISTERED IN THE US, LIST NUMBER 04Z96-51, 510K K213486.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING INSTALLATION OF THE GLP LOADER MODULE (LM), SERIAL (B)(6), WHILE TRYING TO STAND UP, THEY LOST THEIR BALANCE AND TRIED TO BRACE THEIR HAND WHEN IT CONTACTED A SHARP SUPPORT STRUCTURE. DUE TO THE POSITIONING OF THE FSR DURING THE INCIDENT, THEIR HAND STRUCK DOWNWARD AND THEN LATERAL ON THE METAL STRUCTURE AT THE BOTTOM OF THE MODULE, CREATING 3 LACERATIONS TO THE FINGERS. TWO OF THE FINGERS REQUIRED STITCHES AND IT WAS NOTED THAT THE THIRD WAS A SUPERFICIAL CUT. NO FURTHER TREATMENT BY THE FSR WAS REPORTED. THE FSR ALSO STATED THAT NO SAFETY GLOVES WERE WORN AT THE TIME OF THE INCIDENT. CURRENT LABELING PROVIDES WARNINGS AND CAUTIONS SERVICE PERSONNEL TO WEAR SAFETY GLOVES TO AVOID CUT INJURIES WHILE PERFORMING THE INSTALLATION OF THE GLP LOADER MODULE FOR THE GLP ARCHIVE II. A REVIEW OF COMPLAINT AND TRENDING DATA FOR THE GLP LOADER MODULE DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE ISSUE DESCRIBED IN THIS COMPLAINT. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE ISSUE IS CONSIDERED A USE ERROR AS THE FIELD SERVICE PERSONNEL DID NOT WEAR SAFETY GLOVES DURING INSTALLATION OF THE GLP LOADER MODULE. BASED ON THE AVAILABLE INFORMATION THE GLP LOADER MODULE, SERIAL (B)(6), IS PERFORMING AS INTENDED. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE GLP LOADER MODULE WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) WAS AT THE CUSTOMER SITE FOR A NEW INSTALL OF THE GLP LOADER MODULE. THE FSR LOST HER BALANCE AND TRIED TO BRACE HERSELF. HER HAND HIT A SHARP STRUCTURE ON THE GLP LOADER MODULE AND CUT THREE OF HER FINGERS. TWO OF HER FINGERS REQUIRED STITCHES. NO FURTHER IMPACT OR TREATMENT TO THE FSR WAS REPORTED.

    Description of Event or Problem · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) WAS AT THE CUSTOMER SITE FOR A NEW INSTALL OF THE GLP LOADER MODULE. THE FSR LOST HER BALANCE AND TRIED TO BRACE HERSELF. HER HAND HIT A SHARP STRUCTURE ON THE GLP LOADER MODULE AND CUT THREE OF HER FINGERS. TWO OF HER FINGERS REQUIRED STITCHES. NO FURTHER IMPACT OR TREATMENT TO THE FSR WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820045 GLP LOADER MODULE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT AUTOMATION SOLUTIONS GMBH 00380740204143

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention