BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-508LUB EA INSULIN BL EN US LN

    MDR report key: 1063158 · Received June 20, 2008

    Report

    Report Number
    2032227-2008-01030
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 10, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K990801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE AMY 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 REPORTED THAT THE PASSED OUT AND WAS TAKEN TO THE HOSPITAL DUE TO HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS NOT REPORTED. IT WAS STATED THAT THE DOCTOR DETERMINED THAT THE CUSTOMER HAD A RARE VIRUS IN HIS LUNGS. THE CUSTOMER ALSO REPORTED BEING STRESSFUL AND HAVING TO WORK LONG HOURS THE CUSTOMER STATED THAT THE BASAL RATES WERE CHANGED AND STILL DIDN'T SOLVE THE LOW BLOOD GLUCOSE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-508LUB EA INSULIN BL EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-508LUB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization