BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3062043 · Received April 16, 2013

    Report

    Report Number
    2032227-2013-01410
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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. NO DAMAGE TO THE SCREEN WAS NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE FELL DUE TO NEUROPATHY IN HER LEGS, AND THE INSULIN PUMP BROKE. THE CUSTOMER WENT TO THE HOSPITAL, AND WAS TREATED FOR A HIGH BLOOD GLUCOSE OF 312 MG/DL. THE CUSTOMER ALSO REPORTED A BLANK SCREEN AND A FULL SEGMENT DISPLAY ON THE INSULIN PUMP. 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
    163518 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization