BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2202536 · Received August 5, 2011

    Report

    Report Number
    3004209178-2011-82469
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING UNEXPLAINED HIGH BLOOD GLUCOSE, BLANK DISPLAY, AND LOW BATTERY LIFE. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT HE WENT TO THE DOCTOR'S OFFICE FOR ASSISTANCE WITH TREATING HIS HIGH BLOOD GLUCOSE OF 458MG/DL. THE CUSTOMER WAS TREATED WITH MANUAL INJECTIONS. THE CUSTOMER STATED THAT THE DOCTOR CHECKED THE SETTINGS ON THE INSULIN PUMP AND THEY WERE CORRECT AND ACCURATE. INSULIN EXITED DURING THE FIXED PRIME TEST AND THE INSULIN PUMP PASSED THE HIGH PRESSURE TEST. ATTEMPTED TO COMPLETE TROUBLESHOOTING, BUT THE DOCTOR RECOMMENDED HAVING THE INSULIN PUMP REPLACED. THE CUSTOMER STATED THAT THE INSULIN PUMP HAS INTERMITTENT BLANK DISPLAY. 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 43 YR Hospitalization