BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-722PNAH PRDGM V2.4 PK EN PW

    MDR report key: 1667353 · Received April 23, 2010

    Report

    Report Number
    2032227-2010-80997
    Event Type
    Death
    Date Received
    April 23, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 6, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 STATED THAT THE CUSTOMER PASSED AWAY WHILE WEARING THE INSULIN PUMP. THE INSULIN PUMP WAS DOWNLOADED, AND IT SHOWED THAT THE CUSTOMER CHECKED HER BLOOD GLUCOSE READING ONLY ONCE, ON THE DAY THAT SHE PASSED. THE CUSTOMER GAVE A 7.0 UNIT BOLUS FOR A BLOOD GLUCOSE READING OF 450 MG/DL, AND HAD BEEN EXPERIENCING BLOOD GLUCOSE LEVELS BETWEEN 300 AND 400 MG/DL FOR A WHILE. IT WAS ALSO STATED THAT THE CUSTOMER SUFFERED FROM DEPRESSION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722PNAH PRDGM V2.4 PK EN PW INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722PNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death