BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2092398 · Received May 3, 2011

    Report

    Report Number
    3004209178-2011-81305
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    April 23, 2011
    Report Date
    April 23, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    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 THAT THE INSULIN PUMP WAS NOT DELIVERING INSULIN. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 500MG/DL. THE CUSTOMER STATED THAT HE TOOK 25 UNITS WITH THE INSULIN PUMP AND 14 UNITS WITH A MANUAL INJECTION. THE CUSTOMER ALSO REPORTED HAVING UNEXPLAINED HIGH BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, BASALS, BOLUS, AND DAILY TOTALS WERE CORRECT. THE CUSTOMER STATED EATING CARBOHYDRATES AND NOT BOLUSING FOR THEM. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR