BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3073697 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-92721
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 30, 2013
    Report Date
    March 31, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE HAD UNEXPLAINED HIGH BLOOD GLUCOSE OF OVER 300MG/DL. CUSTOMER STATED THAT HIS INSULIN PUMP HAS A RECURRING NO DELIVERY ALARM AND HE DOES NOT HAVE A BACK-UP PLAN. CUSTOMER STATED THAT HE IS GOING TO THE HOSPITAL FOR THE HIGH BLOOD GLUCOSE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174735 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization