BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4862426 · Received June 23, 2015

    Report

    Report Number
    2032227-2015-19912
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    January 1, 2015
    Report Date
    June 15, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL TO HAVE BEEN HOSPITALIZED ON (B)(6) 2015 WITH BLOOD GLUCOSE OF 578 MG/DL. CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. CUSTOMER HAD SYMPTOMS OF SWEATING, DIZZY, HEADACHE, SHAKING AND LIGHT HEADED. CUSTOMER WAS NOT HOSPITALIZED BUT WAS OBSERVED FOR A FEW HOURS AND WAS TREATED WITH IV DRIP AND INSULIN VIA SYRINGE. CUSTOMER WAS WEARING INSULIN PUMP AT THE TIME OF HOSPITALIZATION. CUSTOMER REPORTED THAT HIGH BLOOD GLUCOSE WAS CAUSED BY DAMAGE TO RESERVOIR COMPARTMENT WHICH CAUSED INSULIN PUMP TO LEAK. CUSTOMER WAS ADVISED THAT INSULIN PUMP WOULD NEED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407348 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR