BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3801046 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-84384
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 30, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTED HOSPITALIZATION DUE TO DIABETES KETOACIDOSIS. CALLER STATED THAT CUSTOMER HAD BENT CANNULAS. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 655 MG/DL. HOSPITAL TREATED WITH IV FLUIDS AND INSULIN DRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277614 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization