BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP

    MDR report key: 3903563 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-86341
    Event Type
    Death
    Date Received
    June 30, 2014
    Date of Event
    April 5, 2014
    Report Date
    April 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. VISUAL INSPECTION REVEALED A CRACKED RESERVOIR TUBE LIP. THE DELIVERY VOLUME ACCURACY TEST IS PENDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY AFTER EXPERIENCING A MASSIVE HEART ATTACK WHILE RIDING HIS BIKE. THE CALLER STATED THAT THE PATIENT WAS WEARING THE PUMP AT THE TIME OF HIS DEATH. THE PATIENT'S LAST BG READING WAS UNKNOWN. THE PATIENT'S WIFE AGREED TO RETURN THE PUMP FOR ANALYSIS. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379756 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death