BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET

    MDR report key: 19421597 · Received May 29, 2024

    Report

    Report Number
    3003442380-2024-04602
    Event Type
    Injury
    Date Received
    May 29, 2024
    Date of Event
    April 10, 2024
    Report Date
    August 16, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016712
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MDR DEVICE 5 OF 6. E1: PATIENT CITY: (B)(6) PATIENT COUNTRY (B)(6) .

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2024-04602. CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED COMMON DEVICE NAME UNDER D2, MODEL NUMBER, SERIAL NUMBER, PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) NUMBER UNDER D4. ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY: THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED FOR THE MALFUNCTION CODE SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE. THE BATCH 6003182 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. THE REFERENCE SAMPLES FOR BATCH 6003182 WERE PREVIOUSLY TESTED IN 1859818 ON 24/APR/2024. DEVICE HISTORY RECORD (DHR) REVIEW: PACKING: LOT 6003182 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 106 IN THE LINE L-7, ON 08/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 11/AUG/2025 AGAINST MALFUNCTION CODE SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE AND LOT 6003182 AND OTHER 3 COMPLAINTS HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6003182 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: THIS IS A COMPLAINT WHICH IS BEING ADDRESSED AS PART OF A CORRECTIVE AND PREVENTIVE ACTION (CAPA) 1768101: "AUTOSOFT 90, KINKED SOFT CANNULA ISSUES WHICH HAS BEEN OPENED AS A RESULT OF TRENDING ACTIVITIES. THIS COMPLAINT IS A REPORTABLE WITH VALID LOT NUMBER/PRODUCT CODE.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4) EVENT OCCURRED IN UNITED STATES IT WAS REPORTED THAT PATIENT FACED SIX INFUSION SET CANNULA BENT EVENTS, THREE OCCURRED ON 10-APR-2024 AND THREE OCCURRED ON 13-APR-2024. THE EVENT OCCURRED AFTER 3 TO 5 HOURS OF INSERTION. THE INSERTION SITE WAS AT ABDOMEN. THE BLOOD GLUCOSE LEVEL AT THE TIME OF EVENT WAS 400 MG/DL AND THERE WERE SEVERE ELEVATED LEVEL OF KETONES. PATIENT RESOLVED IT BY CORRECTION BOLUS VIA PUMP FOLLOWED BY REPLACING INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. HEALTH CARE PERSONNEL (HCP) IDENTIFIED THAT KETONE LEVEL WERE DANGEROUS AND LIFE THREATENING. 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.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099879 INSET UNO INSET I 60/6 BLUE TCAP 10PK INT FPA UNOMEDICAL A/S 1001683 6003182 05705244016712

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male Life Threatening