BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2925785 · Received January 22, 2013

    Report

    Report Number
    2032227-2013-00291
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    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 INCLUDING THE DISPLACEMENT TEST. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING IN THE EMERGENCY ROOM DUE TO BLOOD GLUCOSE OF 360MG/DL, AND HER BLOOD GLUCOSE WAS TREATED WITH AN INSULIN DRIP. THE CUSTOMER EXPERIENCED SYMPTOMS OF DIABETES KETOACIDOSIS, VOMITING, AND NAUSEA. THE CALLER MENTIONED GETTING NO DELIVERY ALARMS IN THREE OCCASIONS. ADVISED TO CALL US BACK WHEN THE ALARM OCCURRED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29405 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization