BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2800642 · Received October 22, 2012

    Report

    Report Number
    3004209178-2012-90228
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    November 13, 2011
    Report Date
    October 11, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE A YEAR AGO. THE CUSTOMER STATED THAT HE HAD THE INSULIN PUMP IN STORAGE FOR OVER A YEAR SINCE HE WAS IN THE HOSPITAL. THE CUSTOMER STATED THAT THE DOCTOR TOLD HIM TO REMOVE THE INSULIN PUMP AND PUT HIM ON MANUAL INJECTIONS FOR A YEAR. INITIALLY THE CUSTOMER CALLED REQUESTING ASSISTANCE WITH UPLOADING THE CARELINK. THE CUSTOMER ATTEMPTED TO UPLOAD MULTIPLE TIMES WITHOUT RESULTS. REVIEWED THE ALARM HISTORY AND FOUND SEVERAL ERROR ALARMS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization