BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4153438 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-35152
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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 THAT SHE EXPERIENCED UNEXPLAINED LOW BLOOD GLUCOSE AS LOW AS 23 MG/DL IN THE MORNING AND UNEXPLAINED HIGH BLOOD GLUCOSE IN THE MID MORNING OF UP TO 458 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631042 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR