BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3143650 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-94352
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 16, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    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 BEING HOSPITALIZED WITH DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 547MG/DL. THE CUSTOMER WAS VOMITING AND EXPERIENCED HIGH GLUCOSE FOR THE PAST FEW DAYS. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD SETTINGS WERE CORRECT. THE ALARM HISTORY REVEALED A LOW RESERVOIR ALARM. THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. ASSISTED THE CALLER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. PERFORMED THE HIGH PRESSURE TEST AND PASSED. THE CUSTOMER MENTIONED THAT THE SITE SHE WAS USING AT THE TIME OF THE EVENT HAS SCAR TISSUE. THE CALLER HAD CHANGED THE SITE, BUT WHEN THE CANNULA WAS REMOVED IT APPEARS A LITTLE BENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244719 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization