BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3882475 · Received June 18, 2014

    Report

    Report Number
    3004209178-2014-85936
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT PASSED THE FUNCTIONAL TEST, INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST AND EXCESSIVE NO DELIVERY TEST. UNIT HAD A SCRATCHED DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE LIP, AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. THE DOCTOR IS RELEASING CUSTOMER WITH MANUAL INJECTIONS AND REQUESTING INSULIN PUMP TO BE EVALUATED. THE CUSTOMER WAS TREATED FOR HIGH BLOOD GLUCOSE, WITH INSULIN DRIP AND MANUAL INJECTIONS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL DURING HOSPITALIZATION WAS 354MG/DL. CUSTOMER MADE AN ATTEMPT TO LOWER HIGH BLOOD GLUCOSE LEVEL WITH BOLUS, AND MANUAL INJECTIONS AND IT WAS UNSUCCESSFUL. UNABLE TO TEST THE DEVICE DUE TO NOT HAVING INFUSION SET. THE BLOOD GLUCOSE READING WAS 218MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357236 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization