BEUDAMED
    FDA Adverse Event Injury Summary report: N

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    MDR report key: 7673063 · Received July 10, 2018

    Report

    Report Number
    3004209178-2018-89735
    Event Type
    Injury
    Date Received
    July 10, 2018
    Date of Event
    June 11, 2018
    Report Date
    August 7, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169656840
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 FAMILY WAS REPORTED VIA PHONE CALL THAT, THE CUSTOMER LOW HIGH BLOOD GLUCOSE OF 44 MG/DL ND COULD NOT FIGURE OUT HOW TO SUSPEND THE PUMP. THE LOW BLOOD GLUCOSE WAS TREATED WITH JUICE AND CURRENT BLOOD GLUCOSE RECORDED WAS 51 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING FOR THE LOE BLOOD GLUCOSE. CUSTOMER WAS ABLE TO SUCCESSFULLY SUSPEND THE PUMP. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516741 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG1P2BL 00643169656840

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other