BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP MMT-751NAS

    MDR report key: 7640401 · Received June 26, 2018

    Report

    Report Number
    3004209178-2018-85340
    Event Type
    Injury
    Date Received
    June 26, 2018
    Date of Event
    May 29, 2018
    Report Date
    August 23, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169503717
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    COMPLAINTS TEXT (B)(6) 2018, ERP_RFC_USER RELATED (B)(4); COMPLAINTS TEXT (B)(6) 2018, ERP_RFC_USER RELATED, SVN (B)(4); COMPLAINTS TEXT (B)(6) 2018, ENGELB6, CALLBACK. (B)(6), (B)(6) 2018, SENSOR-CHARGER NOT STAYING FULLY CHARGED SG V/S BG...540 BG ABOUT 3 WEEKS AGO ...LOSES CONNECTION OUTCOME: CUSTOMER DID NOT ANSWER, LEFT VM ON (B)(6) PUMP SN NOT VERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479104 530G INSULIN PUMP MMT-751NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS A4751NASJ 00643169503717

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other LANCET DEVICE MMT-7510 SNSRTR CMFRT EN| SENSOR ENLITE MMT-7008A