BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 3ML

    MDR report key: 4110584 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27423
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A HIGH BLOOD GLUCOSE OF 407 MG/DL. HE STATED THAT HE HAD BEEN TREATING WITH THE INSULIN PUMP BUT HIS BLOOD GLUCOSE CONTINUES TO BE HIGH. HE ALSO REPORTED THAT HE HAD BEEN CHANGING HIS INFUSION SETS BUT THE PROBLEM PERSISTS. THE CUSTOMER'S CURRENT BLOOD GLUCOSE WAS 339 MG/DL. THE CUSTOMER ALSO REPORTED A NO DELIVERY ALARM WHEN HE WAS ATTEMPTING TO DELIVER A BOLUS. THE CUSTOMER STATED HE HAD TREATED HIS HIGH BLOOD GLUCOSE WITH 8 UNITS OF INSULIN. TROUBLESHOOTING FOUND THERE WAS NOT A LEAK ON THE INSULIN PUMP. THE CUSTOMER WAS ALSO ADVISED TO RUN A 5 UNIT FIXED PRIME. THE CUSTOMER STATED A NO DELIVERY ALARM OCCURRED DURING THE FIXED PRIME. THE CUSTOMER ALSO STATED THE CANNULA WAS NOT OCCLUDED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590463 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC MINIMED MMT-332A H8560731

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR