BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP MMT-751LNAS

    MDR report key: 7232949 · Received January 31, 2018

    Report

    Report Number
    3004209178-2018-47579
    Event Type
    Injury
    Date Received
    January 31, 2018
    Date of Event
    January 21, 2018
    Report Date
    January 31, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169933224
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE OF 600 AND 423 MG/DL. CUSTOMER¿S CURRENT BLOOD GLUCOSE VALUE WAS 357 MG/DL. THE OTHER BLOOD GLUCOSE VALUES ARE 518, 582, 537, 453, 406, 401, 366, 266, 242, 367, 362 AND 357 MG/DL. TROUBLESHOOTING WAS DONE FOR HIGH BLOOD GLUCOSE AND UNDER DELIVERY. THE CUSTOMER TREATED WITH THE PUMP. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. BASED ON CUSTOMER REPORT CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERING. THE CUSTOMER PERFORMED HIGH PRESSURE TEST AND DISPLACEMENT TEST AND BOTH PASSED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76333 530G INSULIN PUMP MMT-751LNAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751LNAS A5751LNASJ 00643169933224

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other