BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3180909 · Received June 20, 2013

    Report

    Report Number
    3004209178-2013-94873
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 30, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, AND NO DELIVERY ALARM TEST. THE DEVICE WAS RECEIVED WITH MOTOR ERROR ALARMS DURING THE OCCLUSION TEST AND WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO MOISTURE DAMAGE INSIDE THE FORCE SENSOR. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE MOTOR ERROR ALARMS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING THE FILLING PROCESS. THE CALLER ATTEMPTED AGAIN AND GOT A NO DELIVERY ALARM. THE CUSTOMER MENTIONED HAVING STOMACH PAIN AND HIGH BLOOD GLUCOSE OVER 500MG/DL THE ENTIRE WEEK. TROUBLESHOOTING WAS PERFORMED AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. ASSISTED THE CALLER TO RUN THE DISPLACEMENT AND SELF TEST AND THEY PASSED. THE MANUAL PRIME WAS COMPLETED AND THE INSULIN DID EXIT. THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD SETTINGS WERE CORRECT. THE HIGH PRESSURE TEST WAS PERFORMED AND THE TEST FAILED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280315 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR