BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP MMT-751NAS

    MDR report key: 8649175 · Received May 29, 2019

    Report

    Report Number
    2032227-2019-08634
    Event Type
    Malfunction
    Date Received
    May 29, 2019
    Date of Event
    May 23, 2019
    Report Date
    February 25, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169503717
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED WITH STRIPPED BATTERY CAP COIN SLOT. DEVICE RECEIVED WITH CRACKED BATTERY TUBE THREAD AND CRACKED RESERVOIR TUBE LIP. THE TEST INFUSION SET AND RESERVOIR DOES LOCK INTO PLACE.

    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 THE PLASTIC PIECES BREAK OFF OF RESERVOIR, BATTERY COVER WAS MANGLED AND PLASTIC WAS DENTED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444982 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 19 YR