BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP MMT-751LNAS

    MDR report key: 8665880 · Received June 4, 2019

    Report

    Report Number
    2032227-2019-11242
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    May 28, 2019
    Report Date
    June 4, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169933224
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 411 MG/DL. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 197 MG/DL AT THE TIME OF INCIDENT. CUSTOMER'S BLOOD GLUCOSE LEVEL DOWN TO 371 MG/DL AND THEN 360 MG/DL. CUSTOMER REPORTS THAT INSULIN EXITED WITH QUICK RELEASE. CUSTOMER DID NOT ALLEGE FOR UNDER DELIVERING. DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER STATED THAT THERE WAS NO AIR BUBBLE AND LEAK. CUSTOMER WAS TREATED WITH MANUAL INJECTION. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460007 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 68 YR Other FRN-UNK-MMT-332A, UNOMED INF SET