BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3110061 · Received May 13, 2013

    Report

    Report Number
    2032227-2013-01924
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 16, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT THE CUSTOMER IS NEW TO INSULIN PUMP THERAPY, AND HAS BEEN EXPERIENCING HIGH AND LOW BLOOD GLUCOSE LEVELS. IT WAS STATED THAT THE PARAMEDICS WERE CALLED FOR ASSISTANCE ON (B)(6). WHEN THEY ARRIVED, THE CUSTOMER'S BLOOD GLUCOSE WAS 127 MG/DL. IT WAS STATED THAT THE CUSTOMER FELT LOW BECAUSE HER BLOOD GLUCOSE LEVELS HAD BEEN RUNNING HIGH FOR SO LONG. IT WAS STATED THAT THE CUSTOMER'S BASAL RATES HAVE SINCE BEEN ADJUSTED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210493 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention