BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED PARADIGM INSULIN PUMP

    MDR report key: 2132255 · Received June 3, 2011

    Report

    Report Number
    2132255
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 19, 2011
    Report Date
    June 2, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) WITH LONGSTANDING TYPE 1 DIABETES MANAGED WITH INSULIN PUMP. TWO EPISODES OF DIABETIC KETOACIDOSIS OCCURRED WITHIN 4 MONTHS, REQUIRING HOSPITALIZATION EACH TIME. INSULIN PUMP REPLACED AFTER SECOND EPISODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIMED PARADIGM INSULIN PUMP INSULIN PUMP MDS MEDTRONIC 722

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization