BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3090733 · Received May 2, 2013

    Report

    Report Number
    3004209178-2013-93070
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 28, 2013
    Report Date
    April 29, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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

    CUSTOMER REPORTED HIGH BLOOD GLUCOSE READING OF 30 MMOL/L. CUSTOMER ADMITTED HIMSELF INTO HOSPITAL. THE INSULIN PUMP'S PROGRAMMING AND HISTORY ARE CORRECT. THE INSULIN PUMP'S FUNCTIONALITY OF MANUAL PRIME AND HIGH PRESSURE TEST ARE CORRECT. DURING THE TESTING OF THE INSULIN PUMP, NO ANOMALIES FOUND. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191387 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715WWS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization