BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3121973 · Received May 21, 2013

    Report

    Report Number
    2032227-2013-01886
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME
    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE HAD UNEXPLAINED HIGH BLOOD GLUCOSE AND DKA. CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS HOSPITALIZED. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE EMERGENCY ROOM VISIT WAS OVER 300 MG/DL. CUSTOMER STATED THAT HE IS A BRITTLE DIABETIC AND HE WAS EXTREMELY THIRSTY PRIOR TO HOSPITALIZATION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225005 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization