BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3920831 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86565
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT PASSED ALL FUNCTIONAL TESTING INCLUDING THE REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. NO EXCESSIVE NO DELIVERY ALARMS NOTED. NO UNEXPECTED BATTERY OUT LIMIT ALARMS WERE NOTED. UNIT RECEIVED WITH CRACKED BATTERY TUBE THREADS AND A SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE HAS BEEN HOSPITALIZED THREE TIMES DUE TO DIABETES KETOACIDOSIS AND HAS DISCONTINUED THE USE OF THE INSULIN PUMP SINCE THE EVENTS. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE HOSPITALIZATION WAS OVER 500 MG/DL IN ALL THREE INSTANCES. TROUBLESHOOTING WAS PERFORMED AND THE DRIVE SUPPORT CAP AND ALL SETTINGS APPEARED TO BE NORMAL. THE HIGH PRESSURE TEST WAS ALSO PERFORMED AND PASSED. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 104 MG/DL AND HAS TREATED WITH A MANUAL INJECTION. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398331 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization