BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4241220 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50073
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD NORMAL BLOOD GLUCOSE LEVELS OF 116 MG/DL. THE CUSTOMER REPORTED A BLANK DISPLAY ON THE INSULIN PUMP. THE CUSTOMER FURTHER REPORTED THAT THERE WERE MULTIPLE LOW BATTERY ALERTS PRIOR TO THE BLANK DISPLAY ON THE INSULIN PUMP. THE CUSTOMER INSTALLED A NEW ALKALINE BATTERY AND THE DISPLAY ON THE INSULIN PUMP RETURNED. THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS STILL RUNNING SLOW THOUGH. THE CUSTOMER DECLINED TO TROUBLESHOOT AND REPORTED THAT THE INSULIN PUMP WAS GOING TO BE REPLACED SOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723812 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR