BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 6079699 · Received November 4, 2016

    Report

    Report Number
    2032227-2016-39762
    Event Type
    Injury
    Date Received
    November 4, 2016
    Date of Event
    April 6, 2016
    Report Date
    April 7, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY EXCESSIVELY. THE CUSTOMER MADE A CORRECTION WITH A PEN BUT DURING THE NIGHT THE CUSTOMER'S BLOOD GLUCOSE LEVEL REACHED 400 MG/DL. THE CUSTOMER SUSPENDED THE USE OF THE INSULIN PUMP. TESTS WERE CONDUCTED ON THE INSULIN PUMP AND IT OPERATED NORMALLY. THE DEVICE WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731927 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other