BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4123602 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29681
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    October 1, 2011
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 REPORTED HE WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. BLOOD GLUCOSE VALUE AT THE TIME OF THE ADMISSION WAS 600 MG/DL. TREATED WITH INSULIN DRIP. CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF HOSPITALIZATION. CUSTOMER STATED THE DEVICE WAS ALARMING NO DELIVERY AND HIS GLUCOSE KEPT GOING UP AND WAS TAKEN TO THE HOSPITAL BY THE AMBULANCE. CUSTOMER STATED THAT HIS DOCTOR THINKS THAT HE OVER TREATED HIMSELF. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600416 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization