BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4141872 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33628
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED WITH DIABETIC KETOACIDOSIS, AFTER HAVING A STROKE. THE CUSTOMER'S BLOOD GLUCOSE WAS OVER 600 MG/DL. HE WAS WEARING THE INSULIN PUMP AT THE TIME OF THE EMERGENCY ROOM VISIT, BUT IT WAS IMMEDIATELY REMOVED. THE CUSTOMER STATED HE REPEATEDLY ATTEMPTED TO DELIVER BOLUSES AND CHANGED THE SITE. THE CUSTOMER'S SYMPTOMS WERE HIGH BLOOD GLUCOSE FOR TWO DAYS BEFORE THE STROKE, NAUSEA, GASTROPARESIS, AND VOMITING. THE CUSTOMER WAS TREATED BY MONITORING CARBOHYDRATE INTAKE AND INTRAVENOUS INSULIN DRIP. TROUBLESHOOTING WAS PERFORMED WITH THE INSULIN PUMP. INSULIN EXITED THE TUBING DURING A MANUAL PRIME AND NO LEAKS WERE FOUND. THE CUSTOMER STATED HE DID SMELL INSULIN IN THE RESERVOIR COMPARTMENT DURING THE WEEK PRIOR TO THE EVENT. THE INSULIN PUMP SETTINGS AND HISTORY WERE CORRECT, WITH NO INDICATION OF DELIVERY IMPEDIMENTS. A HIGH PRESSURE TEST WAS PERFORMED AND PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621490 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization