BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4181477 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39575
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 18, 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
    HI
    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 THAT HE WAS NOT ABLE TO INPUT HIS BLOOD GLUCOSE NUMBERS. THE CUSTOMER ALSO REPORTED THERE WAS A CIRCLE ON HIS INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE WAS 476 MG/DL. HE STATED HE WAS RUNNING HIGH BECAUSE OF HIS EATING HABITS. HE HAD TREATED HIS BLOOD GLUCOSE WITH THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE HAD DECLINED TO 311 MG/DL DURING TROUBLESHOOTING. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661225 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 29 MO