BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP

    MDR report key: 3903560 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-86346
    Event Type
    Death
    Date Received
    June 30, 2014
    Date of Event
    March 23, 2014
    Report Date
    April 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. UNIT WAS RECEIVED WITH SCRATCHED DISPLAY WINDOW AND CASE. UNIT WAS RECEIVED WITH THE ORIGINAL BATTERY AND IT PASSED THE DELIVERY ACCURACY TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA E-MAIL FROM (B)(6) THAT THE CUSTOMER PASSED AWAY. CALLER STATED THAT THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. CALLER STATED THAT THE CUSTOMER HAD HEART PROBLEMS. CALLER ALSO STATED THAT NO AUTOPSY WAS DONE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379746 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death