BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP MMT-751NAS

    MDR report key: 8825275 · Received July 25, 2019

    Report

    Report Number
    2032227-2019-35781
    Event Type
    Malfunction
    Date Received
    July 25, 2019
    Date of Event
    July 16, 2019
    Report Date
    February 20, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169503717
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO FLATTENED DOME SWITCH ON DOWN ARROW BUTTON. CONNECTOR WAS INSPECTED AND LOCKED ON LCD BOARD. NO BUTTON ERROR ALARM DURING TESTING. INSULIN PUMP PASSED DISPLACEMENT TEST AND SELF TEST.

    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 INSULIN PUMP HAD BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 160 MG/DL. THE CUSTOMER STATED THAT THE TIME WAS ADVANCING. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618905 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 56 YR