BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3100684 · Received May 8, 2013

    Report

    Report Number
    2032227-2013-01759
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    March 15, 2013
    Report Date
    April 13, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 HAS CALLED TO REPORT HOSPITALIZATION DUE TO DIABETIC KETOACIDOSIS. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 136 MG/DL. CUSTOMER STATED THAT SHE WAS VOMITING, NAUSEAOUS AND DEHYDRATED. CUSTOMER'S BLOOD GLUCOSE READING AT TIME OF THE EVENT WAS 445 MG/DL. CUSTOMER NOTICED INFUSION SET WAS KINKED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200928 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization