BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4193661 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41421
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE. HE STATED HE HAD TREATED HIS BLOOD GLUCOSE BASED ON HIS SENSOR READINGS, CAUSING HIS BLOOD GLUCOSE TO RUN HIGHER THAN USUAL. THE CUSTOMER'S BLOOD GLUCOSE WAS 340 MG/DL. THE CUSTOMER DID NOT HAVE ANY SYMPTOMS OF HIGH BLOOD GLUCOSE. THE CUSTOMER ALSO DECLINED TO TROUBLESHOOT AS SHE ALREADY TREATED HER BLOOD GLUCOSE WITH THE INSULIN PUMP. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672171 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR