BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4143434 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30101
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK 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 EXPERIENCING UNEXPLAINED HIGH BLOOD GLUCOSE. SHE ALSO REPORTED THAT OCCASIONALLY HER CANNULAS WERE BENT. THE CUSTOMER REPORTED HAVING ISSUES WITH NO DELIVER ALARMS. CUSTOMER ALSO STATED THERE WAS NO MOISTURE EXPOSURE TO HER INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS FROM 350 MG/DL TO 400 MG/DL. THE CUSTOMER STATED SHE TREATED HER HIGH BLOOD GLUCOSE WITH THE INSULIN PUMP AND INJECTIONS. THE CUSTOMER STATED HER DRIVE SUPPORT CAP APPEARED TO BE NORMAL. THE CUSTOMER WS ADVISED TO CHANGE HER ENTIRE INFUSION SET, RESERVOIR, AND INSULIN. THE CUSTOMER DECLINED TO TROUBLESHOOT ANY FURTHER. NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603472 530G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR