BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 5151794 · Received October 15, 2015

    Report

    Report Number
    2032227-2015-56969
    Event Type
    Injury
    Date Received
    October 15, 2015
    Date of Event
    September 28, 2015
    Report Date
    September 29, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMERS MOTHER STATED HAVING ISSUES WITH UNRESPONSIVE BUTTONS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS REPORTED TO BE BETWEEN 260MG/DL TO 420MG/DL. IT IS REPORTED THAT THE CUSTOMER STATES HER SON'S BLOOD GLUCOSE LEVELS ARE VERY HIGH AT NIGHT. IT IS REPORTED THAT THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE, AND REVERT TO BACK UP PLAN PER THEIR HEALTH CARE PROVIDER. IT WAS REPORTED THAT THE DEVICE WAS OUT OF WARRANTY, AND THE OUT OF WARRANTY LETTER WOULD BE SENT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683712 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715WWP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other