BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3894848 · Received June 25, 2014

    Report

    Report Number
    2032227-2014-03385
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CALLER REPORTED THAT HER SON WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 342 MG/DL AND DIABETIC KETOACIDOSIS. THE CUSTOMER HAD UNCONTROLLED BLOOD GLUCOSE AND WAS VOMITING. THE CALLER STATED THAT THEY DO NOT WANT TO TROUBLESHOOT THE INSULIN PUMP BUT INSTEAD WANT IT TO BE REPLACED. THE NIGHT BEFORE THE HOSPITALIZATION THE CUSTOMER TRIED TO CONTROL THE HIGH BLOOD GLUCOSE WITH THE INSULIN PUMP, BUT WAS UNSUCCESSFUL. AT THE HOSPITAL THE CUSTOMER WAS TREATED WITH IV DRIP, POTASSIUM, DEXTROSE AND INSULIN DRIP. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF THE EMERGENCY ROOM VISIT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370484 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization