BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19489596 · Received June 7, 2024

    Report

    Report Number
    3003442380-2024-07026
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    July 23, 2023
    Report Date
    June 7, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016651
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1881862- MDR 3003442380-2024-07026- DEVICE 9 OF 10.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED 10 INFUSION SET CANNULA BENT EVENT ON (B)(6) 2023 AFTER 3 OR MORE HOURS AFTER INSERTION. INSERTION SITE WAS AT ABDOMEN. CUSTOMER REGULARLY ROTATE SITE LOCATION. INSERTION SET HAS BEEN USED MORE THAN 3 HOURS BUT LESS THAN 6 HOURS. THE BLOOD GLUCOSE LEVEL WAS 300-400MG/DL. THE CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. 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
    2095709 AUTOSOFT XC UNO INSET I 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001681 UNKNOWN 05705244016651

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female