BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4211798 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-29321
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    August 31, 2014
    Report Date
    October 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 400 MG/DL. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2014. THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS AND DIABETES KETOACIDOSIS. THE CUSTOMER INDICATED HAVING SYMPTOMS CONSISTENT WITH HIGH BLOOD GLUCOSE LEVELS INCLUDING BEING SICK TO THE STOMACH AND THIRSTINESS. TROUBLESHOOTING WAS DONE. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691987 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization