BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4860575 · Received June 22, 2015

    Report

    Report Number
    3004209178-2015-67629
    Event Type
    Injury
    Date Received
    June 22, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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 VIA PHONE CALL TO HAVE HIGH BLOOD GLUCOSE OF 563 MG/DL, WHICH WAS TREATED. TROUBLESHOOTING WAS PERFORMED ON INSULIN PUMP TO DETERMINE REASON FOR HIGH BLOOD GLUCOSE. DURING TROUBLESHOOTING, CUSTOMER REPORTED TO HAVE AIR BUBBLES IN RESERVOIR. CUSTOMER WAS ASSISTED IN REMOVING AIR BUBBLES. INSULIN PUMP PASSED THE HIGH PRESSURE TEST. CUSTOMER WAS ADVISED TO CHANGE INFUSION SET, RESERVOIR AND INSULIN AND TO CONTACT HEALTHCARE PROFESSIONAL REGARDING UNEXPLAINED HIGH BLOOD GLUCOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402782 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR