BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8825834 · Received July 25, 2019

    Report

    Report Number
    2032227-2019-36064
    Event Type
    Injury
    Date Received
    July 25, 2019
    Date of Event
    July 15, 2019
    Report Date
    July 25, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00763000190439
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE LEVEL BECAUSE OF MOI INFUSION SET WHERE THE TUBE WAS KINKED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF INCIDENT. CUSTOMER ALSO HAD BLOOD GLUCOSE LEVEL OF 307 MG/DL. THE CUSTOMER DID NOT PROVIDE DETAILS REGARDING HOSPITALIZATION. THE CUSTOMER'S MOTHER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622742 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG35APR 00763000190439

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other UNOMED INF SET, FRN-UNK-RSVR