BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4871494 · Received June 26, 2015

    Report

    Report Number
    3004209178-2015-68981
    Event Type
    Injury
    Date Received
    June 26, 2015
    Date of Event
    March 28, 2015
    Report Date
    June 8, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    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 A HIGH BLOOD GLUCOSE BUT NOT HOSPITALIZED. CUSTOMER'S BLOOD GLUCOSE WAS 457 MG/DL. THE CUSTOMER WAS TREATED FOR HIGH BLOOD GLUCOSE WITH MANUAL INJECTION. THE CUSTOMER WAS ADVISED THE 2 HIGH BLOOD GLUCOSE RULE. THE CUSTOMER WAS ADVISED TO CHANGE ENTIRE SET, RESERVOIR AND INSULIN AND TREAT. THE CUSTOMER WAS ADVISED TO CALL WENT TUBING CLAMP RECEIVED TO RUN THE HIGH PRESSURE TEST TO FINISH THE TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413828 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR