BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4850787 · Received June 17, 2015

    Report

    Report Number
    3004209178-2015-66084
    Event Type
    Injury
    Date Received
    June 17, 2015
    Date of Event
    May 28, 2015
    Report Date
    May 29, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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

    THE CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT SHE HAD LOW BLOOD GLUCOSE BUT NOT HOSPITALIZED. CUSTOMER'S BLOOD GLUCOSE WAS 34 MG/DL. THE CUSTOMER WAS TREATED WITH FOOD. CUSTOMER STATED THAT SHE EXERCISED REALLY HEAVY AROUND LUNCH TIME. THE CUSTOMER WAS ADVISED TO MONITOR THE INSULIN PUMP AND CALL BACK IF ISSUES PERSIST. THE CUSTOMER WAS ADVISED THAT THE PUMP IS FUNCTIONING AS DESIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393053 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR