BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4181502 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39595
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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 HER SENSOR WAS BROKEN AND THAT SHE HAD RECEIVED A CHANGE SENSOR ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS 18 MG/DL. SHE STATED SHE HAD TO TREAT HER LOW BLOOD GLUCOSE WITH AN EMERGENCY GLUCAGON PEN. THE CUSTOMER DECLINED TO TROUBLESHOOT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660349 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention