BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4812966 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-61666
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    May 5, 2015
    Report Date
    May 12, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 A FOLLOW UP PHONE CALL THAT SHE HAD EXPERIENCED LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER'S BLOOD GLUCOSE WAS 46 MG/DL. THE CUSTOMER STATED THAT SHE DID NOT KNOW WHETHER SHE SET UP THE THRESHOLD SUSPEND FEATURE OF THE INSULIN PUMP. SHE ADVISED THAT SHE WOULD CALL BACK WHEN SHE WAS ABLE TO CHECK AND TROUBLESHOOT FOR LOW BLOOD GLUCOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355199 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR