BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4790716 · Received May 22, 2015

    Report

    Report Number
    3004209178-2015-58622
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    May 2, 2015
    Report Date
    May 2, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE WAS NOT RECEIVING ALARMS FROM THE SENSOR WHEN HER BLOOD GLUCOSE WAS OVER 400 MG/DL. THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF THE CALL WAS 300 MG/DL. THE CUSTOMER CONFIRMED SHE HAD TREATED THE HIGH BLOOD GLUCOSE. THE CUSTOMER ALSO REPORTED LOW BLOOD GLUCOSE OF 60 MG/DL. THE CUSTOMER DECLINED TO TROUBLESHOOT THE ISSUE. THE CUSTOMER STATED THAT SHE MAY HAVE OVERCOMPENSATED FROM THE AMOUNT OF CARBOHYDRATES THAT SHE ATE. THE CUSTOMER DID NOT RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333976 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR