BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4111799 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27204
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    June 25, 2014
    Report Date
    August 27, 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

    THE INSULIN PUMP WAS RECEIVED WITH NO VIBRATION DUE TO BROKEN VIBRATOR WIRE. THE INSULIN PUMP HAD A CRACKED DISPLAY WINDOW CORNER, RESERVOIR TUBE, AND RESERVOIR TUBE LIP. THERE WERE MINOR SCRATCHES ON THE DISPLAY WINDOW AND THE END CAP STICKER WAS MISSING. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP WOULD NOT VIBRATE. THE CUSTOMER REPORTEDLY DID A SELF-TEST AND THE INSULIN PUMP DID NOT VIBRATE. THE CUSTOMER WAS ADVISED TO REVERT TO A BACK-UP PLAN. THE CUSTOMER'S BLOOD GLUCOSE WAS 7.6 MMOL/L. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590058 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754CMS

    Patients

    Seq Age Sex Outcome Treatment
    1