BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT XC

    MDR report key: 20862296 · Received December 6, 2024

    Report

    Report Number
    3003442380-2024-24753
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    August 30, 2024
    Report Date
    June 3, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244022386
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H11: SINCE NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION, TESTS ON REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH POST MARKETING SURVEILLANCE (PMS) PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WOULD FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE ON MARKET QUALITY REVIEW (OMQR) PROCEDURE. INITIAL AND FINAL MDR 2062069 - MDR 3003442380-2024 -24753 - DEVICE 2 OF 3.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED AN OCCLUSION WHICH LED TO HIGH BLOOD GLUCOSE LEVEL. ALSO, THE PATIENT HAD HIGH KETONES WHICH THE HEALTHCARE PROFESSIONAL DID NOT IDENTIFIED AS LIFE-THREATENING OR DANGEROUS. MOREOVER, THE ISSUE OCCURRED WITH THREE INFUSION SETS. THE BLOOD GLUCOSE LEVEL OF THE PATIENT RANGED BETWEEN 350-400 MG/DL. THE HIGHEST BLOOD GLUCOSE LEVEL RANGED BETWEEN 400-420 MG/DL. THE PATIENT TRIED TO TREAT HIGH GLUCOSE VIA BOLUS VIA PUMP. THEREFORE, ON (B)(6) 2024, THE PATIENT FIRST WENT TO EMERGENCY ROOM FOR 3 TO 4 HOURS DUE TO HIGH BLOOD GLUCOSE LEVEL. DURING HOSPITALIZATION, THE PATIENT RECEIVED FLUIDS OF SALINE, INSULIN, AND UNSPECIFIED MEDICATION (DRUG NAME UNKNOWN) INTRAVENOUSLY AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. ON THE SAME DAY, THE PATIENT WAS RELEASED FROM THE HOSPITAL WITH NO PERMANENT DAMAGE. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2291957 AUTOSOFT XC UNO INSET I 12/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1006922 UNKNOWN 05705244022386

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Male Life Threatening| R