BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2234062 · Received August 29, 2011

    Report

    Report Number
    2032227-2011-02199
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 17, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    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

    THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED WITH HIGH BLOOD GLUCOSE LEVELS AND KETONES. THE REPORTED BLOOD GLUCOSE READING WAS 475 MG/DL. THE CUSTOMER HAD BEEN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS FOR THE PAST 24 HOURS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. THE CUSTOMER ALSO REPORTED RED AND SWOLLEN INSERTION SITES ON OCCASION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization UNOMEDICAL QUICK-SET PARADIGM INSULIN INFUSION SET| MMT-397, LOT 9202130