BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3203226 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-95321
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 12, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED IT WAS OPERATING WITHIN SPECIFICATIONS. THE DEVICE PASSED ALL FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING IN THE INTENSIVE CARE UNIT DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OVER 600MG/DL. THE CUSTOMER STATED THAT SHE DID NOT BOLUS FOR A FEW DAYS BECAUSE SHE LOST HER BLOOD GLUCOSE METER. THE CUSTOMER EXPERIENCED NAUSEA AND STOMACH PAIN. 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 ERROR ALARMS AND AUTO OFF ALARMS. ASSISTED THE CALLER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. PERFORMED A HIGH PRESSURE TEST AND PASSED. THE SELF TEST WAS CONDUCTED AND FAILED. EXPLAINED THE CUSTOMER THAT THE BENT CANNULA MAY HAVE CONTRIBUTED TO THE HIGH BLOOD GLUCOSE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302237 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization