BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 24825670 · Received April 9, 2026

    Report

    Report Number
    3003442380-2026-86249
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 11, 2026
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FPA
    UDI-DI
    05705244017931
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MDR (B)(4) / INITIAL 4 OF 5. IMDRF CLINICAL SIGNS: TAKEN E010701 AS CODE E0207 IS NOT AVAILABLE IN DATABASE TO CAPTURE FOR USAGE PROBLEM IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 8021545 MANUFACTURING SITE: 3003442380.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO HYPERGLYCEMIA EVENT ON (B)(6) 2026. THE BLOOD GLUCOSE LEVEL WAS 500 MG/DL AND THE PATIENT WAS TREATED WITH FOUR BAGS OF INTRAVENOUS FLUIDS AND INSULIN. THE LENGTH OF HOSPITALIZATION IS MORE THAN TWENTY-FOURS. PATIENT REPORT FIVE INFUSION SET ISSUES DUE TO SCARRED TISSUE HARDENED TISSUE OR STRETCH MARKS. THE INSERTION SITE WAS ABDOMEN. PATIENT EXPERIENCED DELIRIUM AND VOMITING. PATIENT FOUND POSITIVE FOR KETONES AND LEVELS FOUND DIABETIC KETOACIDOSIS. THE INFUSION SET WAS IN USE FOR ONE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886311 QUICK SET SET, ADMINISTRATION, INTRAVASCULAR FPA MEDTRONIC MINIMED MMT-398A 6011372 05705244017931

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown