BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3791220 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-84331
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BATTERY ERROR. CUSTOMER REMOVED THE BATTERY AND IT HOT AND THE INSULIN PUMP IS NOT WORKING. CUSTOMER WOKE UP AND THE INSULIN PUMP WAS DEAD. THE INSULIN PUMP WAS DROPPED ABOUT ONE MONTH AGO AND THE BOTTOM POPPED OUT. CUSTOMER PUSHED IT BACK IN AND GLUED THE PARTS. THE INSULIN PUMP HAS COSMETIC DAMAGE. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WILL BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268484 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR