BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-522LNAS PRDGM INS SK EN ML

    MDR report key: 1673165 · Received April 30, 2010

    Report

    Report Number
    2032227-2010-81098
    Event Type
    Death
    Date Received
    April 30, 2010
    Date of Event
    March 21, 2010
    Report Date
    April 13, 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

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS STATED THAT THE CUSTOMER PASSED AWAY AFTER EXPERIENCING CARDIAC ARREST. THE CUSTOMER WAS WEARING THE INSULIN PUMP PRIOR TO DEATH, AND HAD BEEN EXPERIENCING DIFFICULTY KEEPING HER BLOOD GLUCOSE LEVELS UNDER CONTROL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522LNAS PRDGM INS SK EN ML INFUSION PUMP LZG MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death