BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4211996 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-39902
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    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 THAT SHE HAD FOUR SENSORS FAILED. CUSTOMER STATED THAT THE SENSOR WAS NOT COMMUNICATING WITH THE INSULIN PUMP. CUSTOMER WAS NOT ABLE TO CALIBRATE; THE SIGNAL VALUE WAS CONSISTENTLY AT ZERO. CUSTOMER ALSO STATED THAT THE INSULIN PUMP ALARMED BUT WAS NOT SURE OF THE ALARM. CUSTOMER WAS NOT ABLE TO FINISH THE CALL AS SHE WAS GOING INTO A MEETING. IT WAS ATTEMPTED TO REACH THE CUSTOMER AFTERWARDS BUT CONTACT WAS UNSUCCESSFUL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693390 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR