BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4223855 · Received October 31, 2014

    Report

    Report Number
    2032227-2014-45972
    Event Type
    Injury
    Date Received
    October 31, 2014
    Date of Event
    September 26, 2014
    Report Date
    October 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    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

    CUSTOMER REPORTED SHE WENT TO THE EMERGENCY ROOM BECAUSE OF HIGH BLOOD GLUCOSE. CUSTOMER REPORTED BLOOD GLUCOSE WAS IN THE 400 MG/DL RANGE BROUGHT THEM DOWN TO AROUND 250 MG/DL. CUSTOMER'S BLOOD GLUCOSE WAS 223 MG/DL. CUSTOMER TREATED WITH MANUAL INJECTIONS TO BRING DOWN BLOOD GLUCOSE. CUSTOMER STATED, SHE WAS SLEEPING AND THEN STARTED THROWING UP. CUSTOMER WASN'T IN AN ACCIDENT. CUSTOMER WAS WEARING THE DEVICE DURING EMERGENCY VISIT. CUSTOMER WAS UNABLE TO PERFORM TROUBLESHOOTING. CUSTOMER STATED HE HAD CALLED (B)(6) TO REPORT HIGH BLOOD GLUCOSE AND TROUBLESHOOTING WAS DONE PRIOR TO HOSPITALIZATION. CUSTOMER REPORTED HIGH BLOOD GLUCOSE OF 223 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698116 530G INSULIN PUMP OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization