BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1033879 · Received April 24, 2008

    Report

    Report Number
    2032227-2008-00707
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    February 22, 2008
    Report Date
    April 12, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    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. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    A NURSE CALLED TO REPORT THAT THE CUSTOMER HAD BEEN HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS AND SHE LEFT THE INSULIN PUMP AT THE HOSPITAL. THE CUSTOMER WAS CONTACTED AND SHE STATED THAT HER DOCTOR TOOK HER OFF THE INSULIN PUMP, SO SHE DECIDED TO LEAVE THE INSULIN PUMP AT THE HOSPITAL AND HAVE IT DONATED. OFFERED TO TROUBLESHOOT THE INSULIN PUMP, BUT THE CUSTOMER DECLINED.

    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