BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1150035 · Received August 27, 2008

    Report

    Report Number
    2032227-2008-01469
    Event Type
    Malfunction
    Date Received
    August 27, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 14, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 COMPLAINED OF HIGH BLOOD GLUCOSE LEVELS. THE REPORTED BLOOD GLUCOSE LEVEL WAS 278 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP FAILED THE HIGH PRESSURE TEST. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACKUP PLAN UNTIL A REPLACEMENT INSULIN PUMP COULD BE DELIVERED TO HER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1