BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INSULIN PUMP

    MDR report key: 2830340 · Received November 7, 2012

    Report

    Report Number
    MW5027578
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 26, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC QUICK-SET FOR INSULIN PUMP DEFECTIVE - ATTACHMENT END AND TUBING FILLED WITH A DRY, RED SUBSTANCE. SUSPECTED CONTAMINATION OF PRODUCT COULD HAVE LEAD TO SERIOUS HEALTH CONSEQUENCES FOR PT DUE TO CONTINUOUS DOSAGE THROUGH TUBING TO CONTROL DIABETIC CONDITION. DOSE OR AMOUNT: 20U/HOUR 3:1 DOSE FOR CARBS, CONTINUOUS. DATES OF USE: AFTER SEEING DEFECT DIDN'T USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INSULIN PUMP QUICK-SET FPA MEDTRONIC MINIMED MMT-392 657538

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention