BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3945565 · Received July 21, 2014

    Report

    Report Number
    3004209178-2014-87850
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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

    WHILE ASSISTING THE CUSTOMER WITH PROGRAMMING THEIR INSULIN PUMP THE DEVICE ALARMED MOTOR ERROR. THE CUSTOMER'S BLOOD GLUCOSE WAS 184 MG/DL. AT THE TIME THE CUSTOMER WAS TRYING TO PRIME THE DEVICE. THE DEVICE WAS NOT EXPOSED TO A STRONG MAGNETIC FIELD OR MRI. THE CUSTOMER IS NOT USING THE SENSOR FEATURE. THEY ARE ABLE TO REWIND THE DEVICE. THE CUSTOMER STATED THAT THEY WERE PUTTING THE RESERVOIR AT AN ANGLE AND THE DEVICE ALARMED MOTOR ERROR. THE CUSTOMER STATED THAT THEY DO NOT WANT TO REPLACE THE DEVICE SINCE THEY WILL BE GETTING A NEW INSULIN PUMP SOON. THEY DECLINED REPLACEMENT. THE DISCONTINUATION OF THE DEVICE WAS ADVISED AND THE CUSTOMER STILL DECLINED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425033 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR