BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 5994515 · Received October 3, 2016

    Report

    Report Number
    2032227-2016-25679
    Event Type
    Injury
    Date Received
    October 3, 2016
    Date of Event
    September 10, 2010
    Report Date
    September 12, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT IN THE FIRST SIX MONTHS OF HER INSULIN PUMP THERAPY HER BLOOD GLUCOSE WOULD INCREASE TO OVER 500 MG/DL AT TIMES. THE PATIENT WOULD TREAT BY CHANGING HER SITES AND SET MATERIALS. TROUBLESHOOTING WAS DECLINED FOR THE HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WOULD DECREASE ONCE SHE TREATED. NO PRODUCTS WERE RETURNED OR REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646890 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other