BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-522NAS PRDGM INS V2.2 SK EN

    MDR report key: 1673162 · Received April 30, 2010

    Report

    Report Number
    3004209178-2010-81144
    Event Type
    Death
    Date Received
    April 30, 2010
    Date of Event
    April 5, 2010
    Report Date
    April 12, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    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 FUNCTIONING TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. SEE ALSO MFR REPORT NUMBER 2032227-2010-81093.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY. THE CAUSE OF DEATH WAS A MOTORCYCLE ACCIDENT. IT WAS REPORTED THAT ANOTHER MOTORIST LOST CONTROL OF THEIR VEHICLE AND CAUSED THE ACCIDENT. THE REPORTER STATED THAT THE EVENT WAS NOT DIABETES RELATED. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAS PRDGM INS V2.2 SK EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death