BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2231409 · Received July 18, 2011

    Report

    Report Number
    3004209178-2011-82171
    Event Type
    Malfunction
    Date Received
    July 18, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 30, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED, FAILED THE DISPLACEMENT TEST AND ALARMED MOTOR ERROR DURING REWIND AS A RESULT OF A MOTOR ENCODER SIGNAL BEING OUT OF PHASE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING THE REWIND PROCESS. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT SHE WAS WEARING THE INSULIN PUMP WHILE HAVING AN MRI FOR HER KNEE. THE CUSTOMER STATED THAT SHE WAS UNABLE TO PERFORM THE DISPLACEMENT TEST BECAUSE THE INSULIN PUMP CONTINUED TO ALARM MOTOR ERROR. ADVISED THE CUSTOMER TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN. 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 60 YR