BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4193627 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41321
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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. (B)(4)

    Description of Event or Problem · 1

    CUSTOMER REPORTS TO HAVE EXPERIENCED BLOOD GLUCOSE VERSUS SENSOR GLUCOSE DIFFERENCES WITH THRESHOLD SUSPEND WHEN BLOOD GLUCOSE WERE NOT LOW. CUSTOMER STATES SENSOR GLUCOSE WAS 55 AND BLOOD GLUCOSE WAS 300 MG/DL. CUSTOMER STATES SHE RECEIVED A THRESHOLD SUSPEND AND BLOOD GLUCOSE WAS NOT LOW. CUSTOMER DECLINED TROUBLESHOOTING. CUSTOMER WAS ADVISED SENSOR WILL BE SENT TO HER AS A COURTESY. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672589 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR