BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2950639 · Received February 8, 2013

    Report

    Report Number
    2032227-2013-00518
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 20, 2013
    Report Date
    January 20, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH BLOOD GLUCOSE LEVELS GREATER THAN 500 MG/DL. THE CUSTOMER ALSO EXPERIENCED VOMITING AND NAUSEA. THE CALLER STATED THAT THE CUSTOMER IS CURRENTLY OUT OF THE COUNTRY, AND STATED THAT THE INSULIN PUMP WAS NOT DELIVERING PROPERLY BECAUSE EVERY TIME SHE CONNECTS TO IT, HER BLOOD GLUCOSE LEVELS IMMEDIATELY ELEVATE. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53989 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization