BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3831174 · Received May 23, 2014

    Report

    Report Number
    2032227-2014-02470
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT SHE WAS HOSPITALIZED DUE TO UNEXPLAINED HIGH BLOOD GLUCOSE. CUSTOMER STATED THAT THE BLOOD GLUCOSE READING WAS 550 MG/DL. CUSTOMER STATED THAT HER INSULIN PUMP WAS CONSTANTLY ALARMING NO DELIVERY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308210 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization