BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2233956 · Received August 31, 2011

    Report

    Report Number
    3004209178-2011-82801
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 20, 2011
    Report Date
    August 20, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PROD HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING BOLUS/BASAL. TROUBLESHOOTING WAS PERFORMED. REVIEWED THE ALARM HISTORY, AND ASSISTED WITH THE TIME AND DATE SET UP. RAN A REWIND AND MANUAL PRIME AND WAS COMPLETED SUCCESSFULLY. PERFORMED A SELF TEST AND THE TEST FAILED. ADVISED THE CUSTOMER TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN. NO FURTHER INFO 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 65 YR