BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3930518 · Received July 12, 2014

    Report

    Report Number
    3004209178-2014-86763
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 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

    IT WAS STATED THAT THE SENSOR DOES NOT COMMUNICATE WITH THE INSULIN PUMP. UPON CHECKING THE HISTORY OF THE DEVICE THERE WAS A SENSOR END ALARM. THE CUSTOMER STATED THAT THEY GET A LOT OF LOW ALARMS AT NIGHT WHEN THEIR BLOOD GLUCOSE IS NOT LOW. THE CUSTOMER WAS ADVISED THAT THOSE ALARMS ARE CAUSED DUE TO SLEEPING ON THE SITE OR APPLYING PRESSURE ON THE SITE. THE BLOOD GLUCOSE WAS 101 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408793 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR