BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3093714 · Received May 6, 2013

    Report

    Report Number
    2032227-2013-01667
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 9, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 CALLING FROM EMERGENCY ROOM; GETTING TREATED FOR LOW BLOOD GLUCOSE. THE INSULIN PUMP WAS WORN IN A ROOM WITH MRI. CUSTOMER RECEIVED MOTOR ERROR AND BLOOD GLUCOSE WENT DOWN TO 43 MG/DL. THE EMS WAS CALLED FOR LOW BLOOD GLUCOSE; AFTER TREATMENT CUSTOMER'S BLOOD GLUCOSE WENT UP TO 278 MG/DL. TROUBLESHOOTING FOR MOTOR ERRORS, NOTICED ALL OF THE SETTINGS WERE ERASED OUT OF THE INSULIN PUMP. ADVISED CUSTOMER THAT INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196597 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization