BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INUFUSION PUMP MMT-523PNAL

    MDR report key: 1993401 · Received January 21, 2011

    Report

    Report Number
    2032227-2011-00171
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. NO MOISTURE DAMAGE WAS NOTED ON THE ELECTRONIC OR MOTOR ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED REPEATED PROBLEMS WITH AIR BUBBLES. THE CUSTOMER ALSO REPORTED THAT INSULIN LEAKED PAST THE RESERVOIR O-RINGS. THE CUSTOMER STATED THAT THE RESERVOIRS SMELL LIKE INSULIN, BUT ISN'T SURE IF INSULIN LEAKED INTO THE RESERVOIR COMPARTMENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INUFUSION PUMP MMT-523PNAL INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-523PNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR