BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3160665 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-94568
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 23, 2013
    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 430MG/DL. THE CUSTOMER EXPERIENCED HIGH BLOOD PRESSURE AND VOMITING. THE NURSE STATED THAT THE CUSTOMER HAD ANEMIA. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD SETTINGS WERE CORRECT. REVIEWED THE ALARM HISTORY AND FOUND A NO DELIVERY ALARM. ASSISTED THE NURSE TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. THE NURSE MENTIONED THAT THE CUSTOMER HAD ONE BENT CANNULA PREVIOUSLY. ADVISED THE CUSTOMER TO CALL BACK WHEN THE TUBING CLAMP ARRIVES TO CONTINUE TESTING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260632 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization