BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3110045 · Received May 13, 2013

    Report

    Report Number
    2032227-2013-01926
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 11, 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 WAS HOSPITALIZED WITH A HIGH BLOOD GLUCOSE OF 800 MG/DL. CALLED THE CUSTOMER FOR MORE INFORMATION. THE CUSTOMER STATED THAT SHE WENT TO THE HOSPITAL WITH HIGH BLOOD GLUCOSE LEVELS DUE TO HIGH POTASSIUM. THE CUSTOMER STATED THAT HE DOCTOR HAS DECIDED TO TAKE HER OFF OF INSULIN PUMP THERAPY PERMANENTLY, AND GO BACK TO MANUAL INJECTIONS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209924 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization