BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3920870 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86566
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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

    IT WAS REPORTED BY THE CUSTOMER THAT HER CONTINUOUS GLUCOSE MONITORING DEVICE WAS ALARMING EXCESSIVELY AND UPON INQUIRING FURTHER, IT WAS DISCOVERED THAT SHE HAD BEEN TREATED FOR LOW BLOOD GLUCOSE LEVELS ON (B)(6) OF 2014. PARAMEDICS RESPONDED TO THE CUSTOMER'S HOME AND TREATED HER WITH MANUAL INSULIN INJECTIONS. CUSTOMER DECLINED BEING TAKEN TO THE EMERGENCY ROOM. BLOOD GLUCOSE LEVEL WAS 20 MG/DL AT TIME OF HOSPITALIZATION. WHILE TROUBLESHOOTING THE ALARM, CUSTOMER STATED THAT SHE ATTEMPTED TO USE SENSORS BUT SENSORS HAD EXPIRED. CUSTOMER ALSO STATED THAT HER BLOOD GLUCOSE LEVEL WAS 65 MG/DL THE NIGHT PRIOR TO THE EVENT, BUT SHE WAS TOO TIRED TO TREAT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398276 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization