BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3813024 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-84633
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    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 WAS REPORTED THAT THE CUSTOMER EXPERIENCED ABNORMAL HIGH BLOOD GLUCOSE, AND THE DOCTOR STATED THAT THE PISTON IN THE INSULIN PUMP IS TOO LOOSE AS WELL THE DEVICE WAS NOT DELIVERING INSULIN PROPERLY. THE CUSTOMER WOULD LIKE TO HAVE A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291231 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-712WWP

    Patients

    Seq Age Sex Outcome Treatment
    1