BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET I

    MDR report key: 20318925 · Received September 27, 2024

    Report

    Report Number
    3003442380-2024-27373
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    August 8, 2024
    Report Date
    August 29, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244026032
    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 1990986 - MDR 3003442380-2024-27373 - DEVICE 2 OF 2. 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 PMS PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    Description of Event or Problem · 0

    REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED ON (B)(6) 2024 THAT THE PATIENT ENCOUNTERED INFUSION SET CANNULA WAS KINKED WAS KINKED WITHIN 3 HOURS OF INSERTION WHICH LED TO HIGH BLOOD GLUCOSE LEVEL OF 400MG/DL. THE CUSTOMER ADDRESSED THE HIGH BLOOD GLUCOSE BY CORRECTION BOLUS VIA PUMP, WATER, WALK, ETC. THE INSERTION SITE WAS AT ABDOMEN. THE PATIENT CONFIRMED THAT THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION. THE PATIENT REGULARLY ROTATED THE SITE LOCATION. THE ISSUE GOT RESOLVED BY REPLACING THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. FIRST EVENT TOOK PLACE ON 2-MAY AND 2ND EVENT ON 18 JUNE AND 3RD EVENT ON 13 AUGUST. PATIENT ALSO OBSERVED PAIN AND REDNESS AT THE INSERTION SITE. COMPANY 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
    1372586 INSET I INSET I 2-PACK 60/9 GREY TCAP FPA UNOMEDICAL A/S 1010899 UNKNOWN 05705244026032

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female