BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4241882 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50126
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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

    IT WAS REPORTED THE CUSTOMER'S BLOOD GLUCOSE WAS RUNNING HIGHER THAN NORMAL. THE CUSTOMER ALSO REPORTED THAT IT WOULD TAKE FIVE TO SIX CALIBRATIONS BEFORE HE COULD GET AN ACCURATE READING ON HIS SENSOR. THE CUSTOMER ALSO REPORTED AN INFUSION SET LEAK. CUSTOMER DECLINED TO TROUBLESHOOT. THE CUSTOMER'S BLOOD GLUCOSE WAS ALSO UNKNOWN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724169 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR