BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET

    MDR report key: 23152353 · Received September 26, 2025

    Report

    Report Number
    3003442380-2025-14211
    Event Type
    Injury
    Date Received
    September 26, 2025
    Date of Event
    August 12, 2025
    Report Date
    October 13, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 6012424, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 13-OCT-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL 6012424. THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012424 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 121 AND MANUFACTURED IN THE LINE 10 ON 18-MAR-2025, 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 WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. TEST RESULTS: NO PHOTO WAS PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH: - (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST AND - (WI) GUIDANCE FOR FUNCTIONAL SERTER TESTING FOR COMPLAINTS AREA VERSION 2: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST FOR THE CODE INCORRECT INSERTION OF THE SOFT CANNULA. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, 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 THE UNITED STATES. IT WAS REPORTED BY THE PATIENT'S MOTHER THAT THE PATIENT FACED AN EVENT WHERE THE PATIENT DID NOT INSERT INFUSION SET CORRECTLY. THEREFORE, THE PATIENT TRIED TO TREAT WITH MULTIPLE DAILY INJECTIONS. THE HIGHEST BLOOD GLUCOSE LEVEL OF THE PATIENT WAS MORE THAN 1000 MG/DL. ALSO, THE PATIENT HAD SEIZURE. HOWEVER, PATIENT FIRST WENT TO THE EMERGENCY ROOM ON (B)(6) 2025 AND WAS SUBSEQUENTLY HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVEL. FURTHER, THE PATIENT WENT TO INTENSIVE CARE UNIT. DURING HOSPITALIZATION, THE PATIENT RECEIVED FLUIDS OF SALINE, INSULIN, OXYGEN AND UNSPECIFIED MEDICATION (DRUG NAME UNKNOWN) INTRAVENOUSLY AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. THE PATIENT WAS RELEASED FROM HOSPITAL ON (B)(6) 2025 WITH NO PERMANENT DAMAGE. MOREOVER, THE INFUSION SET WAS USED FOR THREE DAYS. 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
    2111706 INSET UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1001680 6012424

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Hospitalization| R