BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4864264 · Received June 23, 2015

    Report

    Report Number
    3004209178-2015-68162
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    December 15, 2014
    Report Date
    June 5, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    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 THAT SHE HAD MANY ISSUES WITH THE SENSORS. THE SENSORS EITHER BENT, DID NOT INSERT, OR FALL OUT. THE CUSTOMER STOPPED USING THE SENSOR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS OVER 400 MG/DL. THE CUSTOMER ALSO HAD A LOW BLOOD GLUCOSE INCIDENT OF 18 MG/DL. SHE LAID DOWN BECAUSE SHE WAS FEELING INCOHERENT. SHE TREATED HER LOW BLOOD GLUCOSE WITH JUICE AND A CANDY BAR. TROUBLESHOOTING WAS DECLINED. THE DEVICE WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406383 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other