BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715RNAP PRDGM INS PL EN ML PR

    MDR report key: 1133288 · Received August 21, 2008

    Report

    Report Number
    2032227-2008-01416
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 13, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PROD HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPETE 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 1200 MG/DL. IT WAS REPORTED THAT WHEN THE NURSE ATTEMPTED TO PRIME THE INSULIN PUMP, IT ALARMED NO DELIVERY. TROUBLESHOOTING WAS PERFORMED WITH THE NURSE, AND THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. IT WAS ALSO FOUND THAT THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715RNAP PRDGM INS PL EN ML PR INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization