BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1821582 · Received August 26, 2010

    Report

    Report Number
    2032227-2010-82474
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    August 7, 2010
    Report Date
    August 7, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT A BUTTON ERROR ALARM AND A FROZEN SCREEN. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE WAS NOT RESOLVED. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    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 28 YR