BEUDAMED
    FDA Adverse Event Injury Summary report: N

    630G INSULIN PUMP

    MDR report key: 6250199 · Received January 13, 2017

    Report

    Report Number
    3004209178-2017-83864
    Event Type
    Injury
    Date Received
    January 13, 2017
    Date of Event
    December 14, 2016
    Report Date
    December 17, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 EXPERIENCED THREE LOW BLOOD GLUCOSE EVENTS. CUSTOMER'S BLOOD GLUCOSE LEVEL DROPPED TO 38 MG/DL ON (B)(6) 2016, 40 MG/DL ON (B)(6) 2016, AND REALLY LOW ON (B)(6) 2016. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS TREATED WITH JUICE AND CANDY. HER BASAL SETTINGS WERE TOO HIGH, CAUSING HER BLOOD GLUCOSE LEVEL TO GO LOW. TROUBLESHOOTING WAS DECLINED. THE DEVICE WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33242 630G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other