BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2800721 · Received October 22, 2012

    Report

    Report Number
    3004209178-2012-90272
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 12, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 649MG/DL, AND HER BLOOD GLUCOSE WAS TREATED WITH AN INSULIN DRIP. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, AND BOLUS WIZARD WERE CORRECT. REVIEWED THE DAILY TOTALS AND FOUND THAT THE CUSTOMER IS SUSPENDING THE INSULIN PUMP EVERY DAY, AND SHE IS NOT GETTING HER BASAL RATES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization