BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLP ALIQUOT MODULE

    MDR report key: 22724878 · Received August 6, 2025

    Report

    Report Number
    3023268435-2025-00012
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    July 18, 2025
    Report Date
    August 22, 2025
    Manufacturer
    ABBOTT AUTOMATION SOLUTIONS GMBH
    Product Code
    JQP
    UDI-DI
    00380740186821
    PMA / PMN Number
    K213486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ABBOTT AUTOMATION SOLUTIONS (AAS) TECHNICAL GROUP PERFORMED AN INVESTIGATION BASED ON THE COMPLAINT INFORMATION. THE AAS TEAM RECEIVED PHOTOS AND SYSTEM LOGS TO FURTHER INVESTIGATE THE ISSUE. NO MECHANICAL OR SOFTWARE ISSUE COULD BE IDENTIFIED. TRENDING REVIEW DETERMINED NO TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES. A REVIEW OF THE LABELING ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED AN ALIQUOT SAMPLE PROCESSED ON THE GLP ALIQUOT MODULE WAS HEMOLYTIC AND CLOUDY WHICH DID NOT MATCH THE PARENT TUBE. ACCORDING TO (B)(6), THE ALQ WAS CREATED FROM THE MOTHER SAMPLE. NO RESULTS WERE GENERATED FROM THE ALIQUOT TUBE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED AN ALIQUOT SAMPLE PROCESSED ON THE GLP ALIQUOT MODULE WAS HEMOLYTIC AND CLOUDY WHICH DID NOT MATCH THE PARENT TUBE. ACCORDING TO TSM, THE ALQ WAS CREATED FROM THE MOTHER SAMPLE. NO RESULTS WERE GENERATED FROM THE ALIQUOT TUBE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568459 GLP ALIQUOT MODULE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT AUTOMATION SOLUTIONS GMBH 00380740186821

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown