BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-515PNAS PRDGM INS SK EN US PW

    MDR report key: 1133259 · Received August 21, 2008

    Report

    Report Number
    2032227-2008-01419
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    May 1, 2008
    Report Date
    August 4, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER'S WIFE COMPLAINED OF INSULIN GELLING IN THE INSULIN PUMP AND OF THE INSULIN PUMP ALARMING MOTOR ERROR. DURING THE PHONE CALL, THE CUSTOMER'S WIFE STATED THAT THE CUSTOMER HAS BEEN IN AND OUT OF THE HOSPITAL SINCE MAY DUE TO HYPERGLYCEMIA. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-515PNAS PRDGM INS SK EN US PW INFUSION PUMP LZG MEDTRONIC MINIMED MMT-515PNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization