BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2033811 · Received March 17, 2011

    Report

    Report Number
    3004209178-2011-80693
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 WITH DIABETIC KETOACIDOSIS, WITH A HIGH BLOOD GLUCOSE READING OVER 800 MG/DL. THE DIABETES EDUCATOR STATED THAT THE LAST RESERVOIR CHANGE WAS ONE DAY PRIOR TO THE EVENT. PROGRAMMING WAS CORRECT AND TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP PASSED THE FIXED PRIME AND THE HIGH PRESSURE TEST. THE DR. AND TRAINER STATED THAT THE PERCEIVED CAUSE OF EVENT WAS DUE TO THE CUSTOMER BOLUSING IMPROPERLY BY RANDOMLY PUTTING IN NUMBERS FOR INSULIN DELIVERY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED REL MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization