BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2791835 · Received October 15, 2012

    Report

    Report Number
    2032227-2012-07400
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    September 30, 2012
    Report Date
    October 1, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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 IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OF 640MG/DL, AND SHE WAS TREATED WITH AN INSULIN DRIP. THE CALLER STATED THAT SHE WAS RELEASED THE SAME DAY AND RETURNED BACK AFTER SEVERAL HOURS. THE CUSTOMER MENTIONED THAT SHE WAS NOT FEELING WELL. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, AND BOLUS WIZARD SETTING WERE CORRECT. ASSISTED THE CUSTOMER TO RUN THE MANUAL PRIME TEST AND THE INSULIN DID EXIT. PERFORMED A HIGH PRESSURE TEST AND PASSED. INSTRUCTED THE CUSTOMER TO CHANGE THE ENTIRE INFUSION SET AND RESERVOIR. ADVISED THAT THE DEVICE IS FUNCTIONING AS DESIGNED AND TO TALK THE DOCTOR ABOUT THE SCAR TISSUE. 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-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization