BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3173976 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-94792
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    April 16, 2012
    Report Date
    June 4, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PATIENT

    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

    INITIALLY, THE CUSTOMER REPORTED HAVING UNEXPLAINED HIGH BLOOD GLUCOSE OF 300MG/D. THE CUSTOMER EXPERIENCED FATIGUE AND MOUTH DRYNESS. THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD SETTINGS WERE CORRECT. AFTER RECEIVING THE TUBING CLAMP, THE HIGH PRESSURE TEST WAS PERFORMED AND PASSED. A FOLLOW UP WAS CONDUCTED, AND FOUND THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE. THE CUSTOMER STATED THAT ONCE HER BLOOD GLUCOSE WENT DOWN TO 300MG/DL, THEY RELEASE HER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274025 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization