BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 1981020 · Received February 2, 2011

    Report

    Report Number
    3004209178-2011-80278
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 21, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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. THE DEVICE WILL BE RETURNED FOR FURTHER ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE OF 434MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT HE CHANGES THE INFUSION SET EVERY FOUR DAYS. ADVISED THE CUSTOMER TO CHANGE THE INFUSION SET EVERY TWO TO THREE DAYS. REVIEWED THE BASALS, BOLUS HISTORY, AND DAILY TOTALS ON THE INSULIN PUMP. RAN A FIXED PRIME TEST AND THE DEVICE PASSED THE TEST. PERFORMED A HIGH PRESSURE TEST AND THE INSULIN PUMP FAILED THE TEST. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization