BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4860726 · Received June 22, 2015

    Report

    Report Number
    3004209178-2015-67751
    Event Type
    Injury
    Date Received
    June 22, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 SHE RECEIVED A REPLACEMENT PUMP TODAY AND EVERYTHING WORKED FINE EXCEPT THE METER WAS NOT LINKING WITH THE PUMP. CUSTOMER'S MOST RECENT BLOOD GLUCOSE WAS 458 MG/DL. CUSTOMER WAS ASSISTED WITH PROGRAMMING THE METER ID INTO THE PUMP. CUSTOMER CHECKED HER BLOOD GLUCOSE AND HER BLOOD GLUCOSE LINKED TO THE PUMP WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402871 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other