BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-722LNAB PRDGM INS BL EN ML

    MDR report key: 1880831 · Received October 19, 2010

    Report

    Report Number
    2032227-2010-83021
    Event Type
    Death
    Date Received
    October 19, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 12, 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 UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. A REQUEST TO RETURN THE DEVICE HAS BEEN MADE AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY AFTER BEING HOSPITALIZED WITH BLOOD GLUCOSE LEVELS OVER 1000 MG/DL. THE CALLER INITIALLY CALLED FOR INFORMATION ON HOW TO RETURN A REPLACEMENT INSULIN PUMP THAT HAD BEEN SENT TO THE CUSTOMER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722LNAB PRDGM INS BL EN ML INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death