BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2791851 · Received October 15, 2012

    Report

    Report Number
    2032227-2012-07427
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    September 29, 2012
    Report Date
    September 29, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    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

    THE CUSTOMER REPORTED BEING AT THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OF 709MG/DL, AND SHE WAS TREATED WITH AN INSULIN DRIP. THE CUSTOMER EXPERIENCED FUZZINESS IN THE HEAD AND STAGGERING. THE CUSTOMER'S GLUCOSE DROPPED TO 167MG/DL AFTER SHE WAS RECONNECTED TO THE INSULIN PUMP AND THEN SHE WAS RELEASED. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, AND BOLUS WIZARD SETTINGS WERE CORRECT. ASSISTED THE CALLER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. ADVISED THE CUSTOMER TO CALL BACK WHEN THE TUBING CLAMP ARRIVES TO CONTINUE TESTING. INSTRUCTED THE CUSTOMER TO CHANGE THE ENTIRE INFUSION SET AND RESERVOIR. SUGGESTED TO REMOVE THE CANNULA AND IT WAS NOT BENT OR OCCLUDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization