BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3083556 · Received April 29, 2013

    Report

    Report Number
    2032227-2013-01555
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 11, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED WITH A LOW BLOOD GLUCOSE OF 34 MG/DL. THE CUSTOMER STATED THAT SHE WAS SHOPPING, AND SUDDENLY FELL DUE TO THE LOW BLOOD GLUCOSE. THE PARAMEDICS WERE CALLED, AND SHE WAS TAKEN TO THE HOSPITAL. THE CUSTOMER FELT UNCOMFORTABLE USING THIS INSULIN PUMP DUE TO FREQUENT LOW BLOOD GLUCOSE LEVELS DURING THE PAST 30 DAYS. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185920 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization