BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-511LWWL PRDGM INS CL EN LN

    MDR report key: 1180070 · Received September 26, 2008

    Report

    Report Number
    2032227-2008-01665
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 19, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K001829
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED AND THE BATTERY LASTED ONLY ONE DAY. IT WAS REPORTED THAT THE CUSTOMER LOST CONSCIOUSNESS AND WAS TAKEN TO THE HOSPITAL DUE TO LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 20MG/DL. VERIFIED THE HISTORY IN THE INSULIN PUMP AND ALARMS NOTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-511LWWL PRDGM INS CL EN LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-511LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization