BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAS PRDGM INSULIN PUMP

    MDR report key: 7907003 · Received September 25, 2018

    Report

    Report Number
    2032227-2018-33156
    Event Type
    Injury
    Date Received
    September 25, 2018
    Date of Event
    September 7, 2018
    Report Date
    September 25, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THEY HAD A LOW BLOOD GLUCOSE VALUE OF 40MG/DL. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL, NOR WAS EMERGENCY MEDICAL SERVICES DISPATCHED AS A RESULT OF LOW BLOOD GLUCOSE VALUES.THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749533 NAS PRDGM INSULIN PUMP PUMP, INFUSION, INSULIN OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FRN RESERVOIRUNO MEDICAL INFSET