BEUDAMED
    FDA Adverse Event Injury Summary report: N

    630G INSULIN PUMP MMT-1715KR 630G

    MDR report key: 12340552 · Received August 19, 2021

    Report

    Report Number
    2032227-2021-182228
    Event Type
    Injury
    Date Received
    August 19, 2021
    Date of Event
    March 1, 2021
    Report Date
    August 18, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000173036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 129 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER DID NOT EXPERIENCED SYMPTOMS DUE TO HIGH BLOOD GLUCOSE. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH INSULIN INFUSION INTRA VENOUS OR DRIP. THE INSULIN PUMP WAS NOT ON AUTO MODE AT THE TIME OF INCIDENT. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER WAS IN THE EMERGENCY ROOM, ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. THE INFUSION SET CANNULA WAS BENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242054 630G INSULIN PUMP MMT-1715KR 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KR HG36W8E 000000763000173036

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other FRN-UNK-RSVR, UNOMED INF SET