BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT XC

    MDR report key: 19429775 · Received May 30, 2024

    Report

    Report Number
    3003442380-2024-04742
    Event Type
    Injury
    Date Received
    May 30, 2024
    Date of Event
    March 1, 2024
    Report Date
    May 30, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1875196 - MDR 3003442380-2024-04742 - DEVICE 4 OF 5. E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: (B)(6).

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED FIVE INFUSION SET CANNULA BENT EVENTS FROM 1-MAR-2024 TO 16-APR-2024. THE EVENT OCCURRED WITHIN 3 HOURS OF INSERTION. THE INSERTION SITE WAS AT ABDOMEN AND THIGH. THE BLOOD GLUCOSE LEVEL AT THE TIME OF EVENT WAS HIGH (SPECIFIC VALUE UNKNOWN). PATIENT RESOLVED IT BY CORRECTION INJECTION VIA MULTIPLE DAILY INJECTION (MDI) FOLLOWED BY REPLACING INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. FOR THE EVENT PATIENT WENT TO EMERGENCY ROOM NEXT DAY AND WAS HOSPITALIZED ON (B)(6) 2024. THE BLOOD GLUCOSE LEVEL WAS OVER 400 MG/DL AT THE TIME OF HOSPITALIZATION AND THERE WERE HIGH KETONE VALUES. THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN AND GOT DISCHARGED FROM HOSPITAL ON (B)(6) 2024. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150988 AUTOSOFT XC UNO INSET I 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001681 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention| H