BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 3945107 · Received July 18, 2014

    Report

    Report Number
    2032227-2014-04576
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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 RECEIVING A NO DELIVERY ALARM ON THE INSULIN PUMP. THE BLOOD GLUCOSE READING WAS 139 MG/DL. CUSTOMER WAS ASSISTED IN PERFORMING A FIXED PRIME AND STATED THAT INSULIN DID EXIT. HE WAS ADVISED TO CHANGE THE ENTIRE INFUSION SET AND UPON REMOVAL CUSTOMER NOTICED THAT THE CANNULA WAS BENT. CUSTOMER LATER REPORTED A HIGH BLOOD GLUCOSE OF 400 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421288 MODEL NOT SPECIFIED OZO OZO MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR