BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712LNAS PRDGM INS SK EN US LN

    MDR report key: 1222028 · Received November 3, 2008

    Report

    Report Number
    2032227-2008-01902
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    October 23, 2008
    Report Date
    October 23, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. THE REPORTED BLOOD GLUCOSE READING WAS 265 MG/DL. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CUSTOMER HAD BEEN BOLUSING ERRATICALLY PRIOR TO THE EVENT. WHEN CHECKING HISTORY FILES, IT WAS DISCOVERED THAT THE INSULIN PUMP HAD ALARMED NO DELIVERY MULTIPLE TIMES. THE PRIME AND HIGH PRESSURE TESTS PASSED. THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712LNAS PRDGM INS SK EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization