BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2133698 · Received June 9, 2011

    Report

    Report Number
    3004209178-2011-81704
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 23, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 DUE TO HIGH BLOOD GLUCOSE LEVELS AND HIGH BLOOD PRESSURE. THE REPORTED BLOOD GLUCOSE READING WAS 725 MG/DL. THE CUSTOMER HAD BEEN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS FOR THE PAST TWO WEEKS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THERE WAS NO TUBING CLAMP FOR THE HIGH PRESSURE TEST. 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 PUERTO RICO OPERATIONS MED-REL MMT-715NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization