BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19838596 · Received July 26, 2024

    Report

    Report Number
    3003442380-2024-16657
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    June 9, 2024
    Report Date
    July 26, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016620
    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 1922513- MDR 3003442380-2024- 16657- DEVICE 2 OF 3.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER 1922513. EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED THREE INFUSION SET CANNULA KINKED EVENT ON 09-JUN-2024. THE PATIENT NOTICED SYMPTOMS WITHIN THREE HOURS OF INSERTION FOR 2 EVENT AND MORE THAN 3 HOURS FOR 1 EVENT. INSERTION SITE WAS ABDOMEN. PATIENT REGULARLY ROTATED SITE LOCATION. FURTHERMORE, PATIENT CONFIRMED THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION. BLOOD GLUCOSE LEVEL WAS NOTICED 250-300 MG/DL AT THE TIME OF EVENT. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN 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 WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1777042 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6003738 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female