BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3920868 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86533
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE UNIT HAD A SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER WAS REPORTING HOSPITALIZATION DUE TO DIABETIC KETOACIDOSIS. THE BLOOD GLUCOSE AT THE TIME OF THE HOSPITALIZATION WAS 500 MG/DL AND THE CUSTOMER WAS TREATED. THE CUSTOMER DECLINED TROUBLESHOOTING. THE BLOOD GLUCOSE AT THE TIME OF THE PHONE CALL WAS 159 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398337 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization