BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3000673 · Received March 12, 2013

    Report

    Report Number
    3004209178-2013-91783
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 26.8MMOL/L. IT WAS STATED THAT THE CUSTOMER TREATED HIS HIGH BLOOD GLUCOSE, BUT IT KEPT ELEVATING UNTIL HE SEEK A MEDICAL ATTENTION. THE PROGRAMMING WAS REVIEWED AND FOUND THAT THE TIME WAS OFF BY ONE HOUR. THE ALARM HISTORY REVEALED TWO LOW RESERVOIR ALERTS. THE MANUAL PRIME AND HIGH PRESSURE TEST PASSED. IT WAS MENTIONED THAT THE CUSTOMER ALSO HAS A MENTAL ILLNESS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102911 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715WWS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization