BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3920289 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86605
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 22, 2014
    Report Date
    June 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    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

    CUSTOMER REPORTED A HIGH BLOOD GLUCOSE EVENT. CUSTOMER PASSED OUT. THE BLOOD GLUCOSE READING WAS OVER 400 MG/DL. CUSTOMER WENT TO THE HOSPITAL BECAUSE OF HIGH BLOOD PRESSURE AND BLOOD GLUCOSE READING WAS 181 MG/DL. THE CURRENT BLOOD GLUCOSE READING IS 400 MG/DL. CUSTOMER IS SICK TO THE STOMACH. CUSTOMER HAS CONTACTED HER PHYSICIAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398160 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization