BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3081685 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-92849
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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 SHE HAD UNEXPLAINED HIGH BLOOD GLUCOSE. CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS HOSPITALIZED. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE EMERGENCY ROOM VISIT WAS 502 MG/DL. CUSTOMER STATED THAT HER INSULIN PUMP DELIVERED INSULIN WILE SHE WAS SLEEPING, AND CAUSE A LOW BLOOD GLUCOSE OF 40 MG/DL. CUSTOMER ALSO STATED THAT THE DRIVE SUPPORT CAP BROKE OFF ON HER INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185183 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization