BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3885201 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-86010
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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. UNIT WAS RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, RESERVOIR TUBE, AND BATTERY TUBE TREADS. DEVICE ALSO HAD A SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR KETOACIDOSIS. BLOOD GLUCOSE LEVEL WAS 350 MG/DL. SYMPTOMS WERE NAUSEA, VOMITING, KETONES, AND CUSTOMER FELT HE HAD A VIRUS. CUSTOMER WAS TREATED WITH IV DRIP. TROUBLE SHOOTING WAS PERFORMED. DRIVE SUPPORT CAP APPEARS NORMAL. NO AIR BUBBLES IN TUBING. NO LEAKS WERE NOTED. TIME AND DATE WERE INCORRECT, TIME AND DATE CORRECTED. BASAL AND BOLUS WERE CORRECT. CHECKED ALARM HISTORY, MULTIPLE LOW RESERVOIR ALARMS FOUND. CHECKED BOLUS HISTORY, ADVISED TO PROGRAM A 0.2 NORMAL BOLUS AND FOUND .200N IN HISTORY. INACCURATE BOLUS HISTORY VERIFIED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN PER DOCTORS' INSTRUCTION. NO FURTHER INFORMATION TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361056 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 45 YR Hospitalization