BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4233768 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48559
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT THE CUSTOMER HAD AN UNEXPECTED RESTART ALARM ON THE INSULIN PUMP. CUSTOMER STATED THAT HE JUST CHANGED THE BATTERY AND RECEIVED THE ALARM. CUSTOMER WAS UNABLE TO CHECK THE ALARM HISTORY BECAUSE THEY WERE UNABLE TO CLEAR THE ALARM. CUSTOMER STATED THAT TEMP BASAL WAS NOT PROGRAMMED BEFORE THE ALARM OCCURRED. CUSTOMER ALSO STATED THAT THE PUMP WAS NOT STORED OR NOT IN USE FOR AN EXTENDED PERIOD OF TIME. CUSTOMER REPORTED THAT THE BUTTONS BECAME UNRESPONSIVE. CUSTOMER STATED THAT THEY WERE IN A VERY HUMID CLIMATE WHILE TRAVELING. CUSTOMER TREATED WITH A MANUAL INJECTION. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 10 MMOL/L. INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ADVISED TO REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL'S INSTRUCTIONS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714680 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1