BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 5819588 · Received July 25, 2016

    Report

    Report Number
    3004209178-2016-62881
    Event Type
    Injury
    Date Received
    July 25, 2016
    Date of Event
    July 2, 2016
    Report Date
    July 2, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    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'S FATHER REPORTED VIA PHONE CALL OF HIGH BLOOD GLUCOSE READINGS FROM THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE READING IS OVER 600 MG/DL. THE FATHER STATED THAT THEY ARE ON VACATION AND THE PUMP IS NOT GETTING INSULIN. THE CUSTOMER GAVE UP TO 15 UNITS AND BLOOD GLUCOSE IS NOT GOING DOWN. THE CUSTOMER HAD SYMPTOMS SUCH AS AGITATION. THE CUSTOMER'S MOTHER ALSO STATED THAT THE DAUGHTER IS ON DIALYSIS AND HAS A PEK TUBE. THE CUSTOMER ALSO HAD A SENSOR READING OF 400 MG/DL. THE CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472839 530G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other