BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712NAS PRDGM INSULIN SK EN

    MDR report key: 1063318 · Received June 18, 2008

    Report

    Report Number
    2032227-2008-01014
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 4, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 FOR DIABETES KETOACIDOSIS. NO BLOOD GLUCOSE READING WAS REPORTED. THE DAILY TOTALS WERE REVIEWED AND WERE CORRECT. A PRIME TEST, FIXED PRIME, AND HIGH-PRESSURE TESTS WERE PERFORMED AND PASSED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712NAS PRDGM INSULIN SK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization