BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3183262 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-94929
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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 INCLUDING THE DISPLACEMENT TEST. THE LOW RESERVOIR ALARMS FUNCTIONS PROPERLY. THE DEVICE HAD CRACKED RESERVOIR TUBE LIP, BROKEN BELT CLIP SLOT, CRACKED BATTERY TUBE THREADS, AND STAINED END CAP STICKER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING ADMITTED IN THE INTENSIVE CARE UNIT DUE TO HIGH BLOOD GLUCOSE OF 690MG/DL. THE CUSTOMER STATED THAT SHE WAS BECOMING DISORIENTED, HAD DROOPING EYE, AND MAY HAD A STROKE. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD WERE CORRECT. REVIEWED THE ALARM HISTORY AND FOUND LOW RESERVOIR AND NO DELIVERY ALARMS. ASSISTED THE CALLER TO RUN A MANUAL PRIME AND THE INSULIN DID EXIT. PERFORMED A HIGH PRESSURE TEST AND PASSED. INSTRUCTED THE CUSTOMER TO REMOVE THE CANNULA AND FOUND IT WAS BENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282605 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 64 YR Hospitalization