BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-515LNAS PRDGM INS V2.1 SK EN

    MDR report key: 1092324 · Received August 1, 2008

    Report

    Report Number
    2032227-2008-01333
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 22, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 DUE TO HYPOGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 26 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE PROGRAMMING ON THE INSULIN PUMP WAS INCORRECT. IT WAS FOUND THAT THE TIME WAS WRONG AND THE BOLUS SETTINGS WERE INCOMPLETE. IT WAS ADVISED THAT THE CUSTOMER SPEAK WITH HER DOCTOR TO DISCUSS THE BOLUS SETTINGS ON THE INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-515LNAS PRDGM INS V2.1 SK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-515LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization