BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 5336874 · Received December 30, 2015

    Report

    Report Number
    2032227-2015-80230
    Event Type
    Injury
    Date Received
    December 30, 2015
    Date of Event
    December 15, 2015
    Report Date
    December 15, 2015
    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

    DOCTOR REPORTED VIA PHONE CALL HIGH BLOOD GLUCOSE LEVELS AND HOSPITALIZATION. CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE, DIABETIC KETOACIDOSIS AND HOSPITALIZATION. DOCTOR ADVISED PATIENT HAS BEEN HOSPITALIZED AS A RESULT OF DIABETIC KETOACIDOSIS SEVERAL TIMES. DOCTOR ADVISED THAT A MEDTRONIC REPRESENTATIVE VISIT WITH THE CUSTOMER TO FIGURE OUT THE ISSUES OF CONSTANT HIGH BLOOD GLUCOSE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858014 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| O