BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2003823 · Received February 7, 2011

    Report

    Report Number
    3004209178-2011-80335
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 26, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP HAD A FROZEN DISPLAY AND UNRESPONSIVE BUTTONS AS A RESULT OF CORRODED KEYPAD TRACES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS NOT WEARING THE INSULIN PUMP FOR AN EXTENDED PERIOD OF TIME, AND THE BATTERY WAS TAKEN OUT. THE CUSTOMER ALSO STATED THAT THE BUTTONS WERE UNRESPONSIVE, AND THE ALARM COULD NOT BE CLEARED. THE BATTERY WAS REPLACED TWICE AND THE DEVICE WAS RESTED, BUT THE BUTTONS STILL DID NOT RESPOND. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR