BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 5533248 · Received March 29, 2016

    Report

    Report Number
    2032227-2016-06648
    Event Type
    Injury
    Date Received
    March 29, 2016
    Date of Event
    December 10, 2013
    Report Date
    December 10, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    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

    CUSTOMER REPORTED VIA PHONE CALL TO HAVE HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE WAS 500 MG/DL. CUSTOMER HAD CHANGED THE INFUSION SET AND RESERVOIR. CUSTOMER MENTIONED THE TUBING WAS ALWAYS AN "U" SHAPE. AFTER TROUBLESHOOTING, CUSTOMER WAS ADVISED SAMPLES OF DIFFERENT INFUSION SETS WOULD BE SENT. CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189176 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other