BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2083248 · Received April 13, 2011

    Report

    Report Number
    3004209178-2011-81047
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 25, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP FAILED THE DISPLACEMENT TEST AND GAVE AN ALARM DURING REWIND DUE TO AN OUT-OF-PHASE MOTOR ENCODER SIGNAL. NO MOTOR ERROR ALARMS WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOTOR ERROR ALARM HAD OCCURRED. THE CUSTOMER STATED THAT THEY WERE ABLE TO REWIND THE INSULIN PUMP AND PASS THE DISPLACEMENT TEST. THE CUSTOMER ALSO STATED THAT AN ALARM OCCURRED DURING A BOLUS AND ANOTHER ALARM OCCURRED MULTIPLE TIMES DURING REWIND. NOTHING FURTHER WAS REPORTED.

    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-722NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR