BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAS PRDGM INSULIN PUMP

    MDR report key: 7906444 · Received September 25, 2018

    Report

    Report Number
    2032227-2018-33151
    Event Type
    Malfunction
    Date Received
    September 25, 2018
    Date of Event
    September 10, 2018
    Report Date
    September 25, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP WAS NOT WORKING. BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER WAS CHANGING NEW BATTERIES. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747712 NAS PRDGM INSULIN PUMP PUMP, INFUSION, INSULIN OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR