BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4233034 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48657
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME
    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 THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE LEVELS OF 42 MG/DL. THE CUSTOMER DECLINED TO TROUBLESHOOT THE LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER REPORTED A METER BG NOW ALERT FROM THE INSULIN PUMP. THE CUSTOMER WAS ASSISTED IN CALIBRATING THE INSULIN PUMP. THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 151 MG/DL AFTER TROUBLESHOOTING THE INSULIN PUMP. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715378 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR