BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2172461 · Received June 17, 2011

    Report

    Report Number
    2032227-2011-01495
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING THE BASIC OCCLUSION TEST AS A RESULT OF A FAULTY FORCE SENSOR. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE MOTOR ERROR ALARM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING UNEXPLAINED HIGH BLOOD GLUCOSE OF 466 MG/DL FOR THE PAST THREE HRS. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. RAN A FIXED PRIME TEST AND THE TEST PASSED. PERFORMED A HIGH PRESSURE TEST AND THE INSULIN PUMP FAILED THE TEST. ADVISED THE CUSTOMER THAT A REPLACEMENT OF THE INSULIN PUMP WILL BE SENT. 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 MINIMED MMT-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR