BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715LNAL PRDGM INS V2.1 CL EN

    MDR report key: 1063305 · Received June 19, 2008

    Report

    Report Number
    2032227-2008-01026
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 8, 2008
    Report Date
    June 8, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    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 HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE WAS READING 298MG/DL. IT WAS REPORTED THAT THE CUSTOMER CHANGE THE INFUSION SET AND IT DID NOT HELP TO LOWER HER GLUCOSE LEVEL. TROUBLESHOOTING WAS PERFORMED. THE BOLUS HISTORY, BASAL RATES, DAILY TOTALS, ALARM HISTORY, TIME, AND DATE WERE CORRECT. RAN A SELF-TEST, FIXED PRIME, AND HIGH-PRESSURE TESTS AND PASSED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715LNAL PRDGM INS V2.1 CL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization