BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715LNAS PRDGM INS V2.1 SK EN

    MDR report key: 1133364 · Received August 22, 2008

    Report

    Report Number
    2032227-2008-01433
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    August 10, 2008
    Report Date
    August 11, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 REPORTED BEING HOSPITALIZED FOR LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 10.4 MG/DL. THE CUSTOMER STATED THAT CURRENTLY SHE IS FIGHTING A BLADDER INFECTION AND HAD HER THYROID MEDICATION INCREASED. TROUBLESHOOTING WAS PERFORMED. THE DATE WAS CORRECT, BUT THE TIME WAS OFF BY AN HOUR. THE PROGRAMMING APPEARED TO BE CORRECT. THE BASAL RATES HISTORY REVEALED THAT THE CUSTOMER HAD MADE SEVERAL CHANGES TO THE BASAL RATES. PERFORMED SELF TEST AND DISPLACEMENT TEST. THE DEVICE PASSED THE TESTS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization