BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4061221 · Received September 4, 2014

    Report

    Report Number
    2032227-2014-16867
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 2, 2014
    Report Date
    August 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 ISSUES WITH THE INSULIN PUMP. CUSTOMER STATES THAT HER BLOOD GLUCOSE READING IS FLUCTUATING. ADVISED CUSTOM THAT THERE CAN BE MANY REASONS FOR HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING IS 304 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540846 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR