BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4130673 · Received September 30, 2014

    Report

    Report Number
    2032227-2014-31228
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP. THE INSULIN PUMP WAS RECEIVED WITH SOFTWARE VERSION 2.5A INSTALLED. THE SOFTWARE VERSION SHOULD BE 2.6A PER THE CONFIG CODE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE AIR BUBBLES AT THE INSERTION SITE OF THE INSULIN INFUSION SET. THERE WERE NO AIR BUBBLES IN THE ENTIRE SET WHEN IT WAS PREPARED AND FILLED. THE ISSUE WAS NOT RESOLVED WITH ANOTHER SET AND RESERVOIR FROM A DIFFERENT LOT. THE INSULIN PUMP PASSED THE HIGH PRESSURE TEST WITH SETS FROM THE NEW LOT. THE CUSTOMER'S BLOOD GLUCOSE WAS 15 MMOL/L. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607769 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554LWWH

    Patients

    Seq Age Sex Outcome Treatment
    1