BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4211813 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44865
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    June 9, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    CUSTOMER REPORTED HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. CUSTOMER STATES THAT THE BLOOD GLUCOSE READINGS WERE HIGH AND THE CANNULA WAS BENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691590 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR