BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED SURE-T

    MDR report key: 20950282 · Received December 17, 2024

    Report

    Report Number
    3003442380-2024-29120
    Event Type
    Injury
    Date Received
    December 17, 2024
    Date of Event
    November 16, 2024
    Report Date
    August 7, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K160648
    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: THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED FOR THE MALFUNCTION CODE NO MALFUNCTION BASED ON COMPLAINT INFORMATION. THE BATCH 6002556 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATION: THE REFERENCE SAMPLES CANNOT BE TESTED BECAUSE THERE WAS NO SPECIFIC MALFUNCTION TO INVESTIGATE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002556 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 94, PACKAGED IN MACHINE M10, ON 17/AUG/2023, 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 WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 06/AUG/2025 AGAINST MALFUNCTION CODE NO MALFUNCTION BASED ON COMPLAINT INFORMATION, HARM CODE UNTREATED DIABETIC KETOACIDOSIS WHICH THE PATIENT IS UNABLE TO SELF-MNG REQ INTERV BY A HCP OR REQ EMERGENCY ADVAN LIFE SUPP TO PREV PERM ORGAN DAMAGE (ELEV BLOOD GLUCOSE LEV AND SYMP E.G. MOD TO LG KETONES, NAUSEA, VOMITING, ABDOMEN PAIN, CONFUSION) AND LOT 6002556 AND NO OTHER COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT NUMBER, HARM CODE AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION, HARM CODE AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION OR 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 PATIENT FACED DIABETIC KETOACIDOSIS EVENT AND EVENTUALLY GOT HOSPITALIZED ON (B)(6)2024. THE BLOOD GLUCOSE LEVEL WAS 237 MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN. 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
    1456264 MINIMED SURE-T UNO CONTACT DETACH G29 80/6 SC1 MIMX FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-866A 6002556

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R