BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2970645 · Received February 20, 2013

    Report

    Report Number
    3004209178-2013-91198
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 25MMOL/L. IT WAS STATED THAT THE DOCTOR BELIEVES THE INSULIN PUMP UNDER DELIVERED INSULIN. IT WAS STATED THAT THE CUSTOMER CHANGES THE INFUSION SET AND RESERVOIR EVERY FOUR DISPLACEMENT. TROUBLESHOOTING WAS PERFORMED AND THE DISPLACEMENT TEST WAS NOT POSSIBLE TO RUN. IT WAS STATED THAT THE DEVICE WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. THE TIME, DATE, AND BOLUS WIZARD SETTINGS WERE CORRECT. THE ALARM HISTORY WAS REVIEWED AND FOUND A NO DELIVERY ALARM. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74407 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522WWB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization