BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2171118 · Received July 11, 2011

    Report

    Report Number
    3004209178-2011-82121
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 26, 2011
    Report Date
    June 27, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 430 MG/DL. IT WAS STATED THAT THE CUSTOMER HAD DRIVEN THRU STATES AND SHE WAS EXPERIENCING HIGH GLUCOSE FOR THE PAST (B)(6). TROUBLESHOOTING WAS PERFORMED. REVIEWED PROGRAMMING AND FOUND THAT THERE WAS NO BOLUS DELIVERED FOR (B)(6). RAN FIXED PRIME AND HIGH PRESSURE TEST AND THE INSULIN PUMP PASSED THE TESTS. 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-522NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization