BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3974655 · Received August 3, 2014

    Report

    Report Number
    2032227-2014-05247
    Event Type
    Malfunction
    Date Received
    August 3, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    NURSE

    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 IS REPORTED THAT CUSTOMER'S INSULIN PUMP WAS UNRESPONSIVE AND HAD A BLANK DISPLAY. CUSTOMER BLOOD GLUCOSE LEVEL AT THE TIME WAS 72 MG/DL. TROUBLE SHOOTING WAS PERFORMED ON THE PUMP AND DISPLAY RETURNED BUT BUTTONS WERE STILL UNRESPONSIVE. CUSTOMER WAS ADVICE TO DISCONTINUE USE OF THE PUMP AND REVERT BACK TO BACKUP PLAN PER HER HEALTH CARE PROVIDER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452397 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR