BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4823732 · Received June 8, 2015

    Report

    Report Number
    3004209178-2015-63367
    Event Type
    Malfunction
    Date Received
    June 8, 2015
    Date of Event
    May 12, 2015
    Report Date
    May 19, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH NO VIBRATOR ALERT DUE TO BROKEN BLACK WIRE ON THE VIBRATOR MOTOR. THE INSULIN PUMP HAS MINOR SCRATCHES ON THE LCD WINDOW.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A VIBRATOR ANOMALY ON THE INSULIN PUMP. CUSTOMER STATED THAT THE INSULIN PUMP NO LONGER VIBRATES. CUSTOMER'S BLOOD GLUCOSE LEVELS WERE NOT INCLUDED IN THE REPORT. PRODUCT IS BEING RETURNED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367846 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR