BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4191276 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41554
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO MOTOR ERROR ALARM WAS NOTED. THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO MOISTURE DAMAGE TO THE FORCE SENSOR RESISTOR. THE EXCESSIVE NO DELIVERY ALARM TEST AND OCCLUSION TEST COULD NOT BE PERFORMED DUE TO THE PRIME ANOMALY. HOWEVER, THE INSULIN PUMP PASSED THE BASIC OCCLUSION TEST AND DISPLACEMENT TEST. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE INSULIN PUMP HAD CRACKED BATTERY TUBE THREADS, A CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW AND A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP HAD BEEN SUFFERING MOTOR ERRORS. HIS BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF REPORTING. THE INSULIN PUMP IS BEING RETURNED. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669157 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LCAS

    Patients

    Seq Age Sex Outcome Treatment
    1