BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722RNAS PRDGM INS SK EN RC

    MDR report key: 1253355 · Received December 2, 2008

    Report

    Report Number
    2032227-2008-02002
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    November 10, 2008
    Report Date
    November 10, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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'S HUSBAND REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS. THE REPORTED BLOOD GLUCOSE READING WAS 600 MG/DL. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE PRIME AND HIGH PRESSURE TESTS PASSED. IT WAS FOUND THAT THE CUSTOMER WAS SITTING WHILE INSERTING THE INFUSION SET AND FILLING THE RESERVOIR WITH COLD INSULIN. THE CUSTOMER WAS ADVISED TO STAND WHEN INSERTING THE INFUSION SET AND TO FILL THE RESERVOIR WITH ROOM TEMPERATURE INSULIN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722RNAS PRDGM INS SK EN RC INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization