BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3150900 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-94488
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 19, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 INCLUDING THE DISPLACEMENT TEST. THE LOW RESERVOIR ALARM FUNCTIONS PROPERLY. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE DEVICE HAD MISSING END CAP STICKER, CRACKED BATTERY TUBE THREADS, AND CRACKED RESERVOIR TUBE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 570MG/DL. THE CALLER STATED THAT THE CUSTOMER WAS BOLUSING, BUT HIS GLUCOSE LEVEL CONTINUED TO GO HIGH UNTIL HE GAVE HIMSELF A SHOT. IT WAS STATE THAT THE CUSTOMER EXPERIENCED THIRST, SWEATY, AND HAD CHEST 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 LOW RESERVOIR ALARMS. ASSISTED THE CALLER TO RUN A MANUAL PRIME AND THE INSULIN DID EXIT. THE WIFE MENTIONED THAT THE STICKER ON THE BACK END OF THE DEVICE WAS MISSING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249796 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 54 YR Hospitalization