BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURE-T

    MDR report key: 21888404 · Received April 23, 2025

    Report

    Report Number
    3003442380-2025-06792
    Event Type
    Injury
    Date Received
    April 23, 2025
    Date of Event
    March 18, 2025
    Report Date
    September 5, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244019317
    PMA / PMN Number
    K041545
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY - (B)(6), PATIENT COUNTRY - UNITED STATES.

    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 REVISION 21 OF 3709030 DOES NOT REQUIRE A COMPLAINT THAT IS TYPE 2 REPORTABLE TO OPEN A CHILD INVESTIGATION. THIS CHILD INVESTIGATION WAS OPENED AGAINST A PREVIOUS REVISION OF (B)(6). COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(6). THE BATCH 6011121, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011121 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 99 AND PACKAGING IN THE MULTIVAC 14 ON 12/JAN/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 4M03285 WAS MANUFACTURED ACCORDING TO WI VERSION 66 AND MANUFACTURED ON THE MACHINES SC05 & SC06, ON 10/JAN/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. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, 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 THAT THE CHILD PATIENT HAD HYPERGLYCEMIA EVENT AT SCHOOL ON (B)(6) 2025. THE BLOOD GLUCOSE LEVEL WAS OVER 400MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED BY MOTHER CHANGING INFUSION SET AND BOLUSED. THE PATIENT ALSO EXPERIENCED BLEEDING AT THE INSERTION SITE THE TRACE KETONES WERE FOUND TO BE 0.1 MMOL/L. 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
    675212 SURE-T UNO CONTACT DETACH G29 60/6 SC1 MIMX FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-864A 6011121 05705244019317

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention