BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 2133665 · Received June 9, 2011

    Report

    Report Number
    2032227-2011-01393
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 23, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    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. 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

    THE CUSTOMER POSTED THE FOLLOWING INFO ON THE BLOG AT (B)(6) THE CUSTOMER POSTED THAT HE HAS NOT BEEN GETTING THE PROPER TRAINING OR HELP FROM MEDTRONIC. THE CUSTOMER STATED THAT SOMEONE FROM THE COMPANY CALLED HIM ONLY TO ASK HIM WHY HE WAS IN THE EMERGENCY ROOM TWICE. THE CUSTOMER DID NOT STATE WHETHER THE EMERGENCY ROOM VISITS WERE DUE TO HIGH OR LOW BLOOD GLUCOSE LEVELS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL NOT SPECIFIED INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization