BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2112802 · Received April 29, 2011

    Report

    Report Number
    3004209178-2011-81271
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 17, 2011
    Report Date
    April 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 HE HAS BEEN HAVING HYPOGLYCEMIC EPISODES EARLY IN THE MORNINGS. THE CUSTOMER STATED THAT THE NIGHT BEFORE HIS BLOOD GLUCOSE WAS 40 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING ON THE INSULIN PUMP WAS ACCURATE. THE AMOUNT OF INSULIN IN THE STATUS SCREEN MATCHED WITH THE UNITS LEFT IN THE RESERVOIR. THE CUSTOMER STATED THAT NO BASAL RATES WERE CHANGED EXCEPT THE ONE THAT CUSTOMER ADJUSTED THE NIGHT BEFORE. THE CUSTOMER STATED THAT THE HISTORY WAS SHOWING A BOLUS OF 2.0 UNITS, BUT HE ONLY ADMINISTERED 1.0 UNIT. INSTRUCTED CUSTOMER TO RUN A TEST BOLUS AND THE BOLUS HISTORY SHOWED ACCURATELY. CUSTOMER'S BLOOD GLUCOSE AT THE END OF CALL WAS 204 MG/DL. NO FURTHER INFORMATION 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-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR