BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET II

    MDR report key: 23070558 · Received September 17, 2025

    Report

    Report Number
    3003442380-2025-13811
    Event Type
    Injury
    Date Received
    September 17, 2025
    Date of Event
    August 18, 2025
    Report Date
    September 2, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6011958, IN QUESTION WAS MANUFACTURED AT THE REYNOSA ID SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 01-SEP-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6011958". THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011958 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 76 AND MANUFACTURED IN THE LINE 05 ON 10-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. TEST RESULTS: NO PHOTO WAS PROVIDED. IN ORDER TO TEST THE PRODUCT, THE RETURNED SAMPLE FROM THE LOT HAVE BEEN REQUESTED. NO RETURNED SAMPLES. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED. NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, ONE COMPLAINT THRESHOLDS IDENTIFIED FOR THE LOT IN QUESTION AND SERIOUS INJURY/DEATH, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN IRELAND. THE MOTHER REPORTED THAT HER DAUGHTER HAD BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS WHILE USING THE INSET INFUSION SET OVER THE PAST SEVERAL DAYS. ACCORDING TO THE MOTHER, HER DAUGHTER'S BLOOD GLUCOSE REACHED CRITICAL LEVELS OF 414MG/DL AND HIGHER, THOUGH THIS DID NOT RESULT IN A MEDICAL EVENT REQUIRING INTERVENTION. THE DAUGHTER ALSO PRESENTED WITH ELEVATED HIGHER KETONE LEVELS. THE MOTHER STATED THAT A HEALTHCARE PROFESSIONAL (NURSE) HAD RECOMMENDED USING AN INFUSION SET FROM A DIFFERENT BOX. UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT ONE OF THE INFUSION SETS HAD DEVELOPED A BEND DURING AN EARLY SET CHANGE, WHICH CONTRIBUTED TO THE HIGH GLUCOSE READINGS. ANOTHER INFUSION SET CONTAINED AIR BUBBLES, AND ALTHOUGH PRIMING TEMPORARILY IMPROVED THE DAUGHTER'S GLUCOSE LEVELS, THEY SUBSEQUENTLY INCREASED AGAIN. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1731039 INSET II UNO INSET II 60/6 GREY Y-CAP 10PAK INT FPA UNOMEDICAL A/S 86-060-52B6 6011958

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown