BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4183108 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40129
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    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

    THE CUSTOMER REPORTED THEY RECEIVED A MOTOR ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 245 MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. THE ALARM HISTORY OF THE INSULIN PUMP SHOWED AND E-70 ALARM. THE CUSTOMER STATED THAT DRIVE SUPPORT CAP APPEARED NORMAL. THE CUSTOMER WAS ADVISED TO REVERT TO THEIR BACK-UP PLAN PROVIDED BY THEIR HEALTH-CARE PROFESSIONAL. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660088 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR