BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3200278 · Received July 1, 2013

    Report

    Report Number
    2032227-2013-02670
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE A PROTRUDED/LOOSE DRIVE SUPPORT DISK. UNABLE TO PERFORM, THE EXCESSIVE NO DELIVERY ALARM TEST DUE TO THE PRIME ANOMALY. THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION AND DISPLACEMENT TESTS. THE INSULIN PUMP HAD A MISSING END CAP STICKER. NO STRANGE NOISES WERE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED BLOOD GLUCOSE LEVELS GREATER THAN 300 MG/DL FOR WEEKS. THE CUSTOMER ALSO OBSERVED NOISES COMING FROM THE INSULIN PUMP DURING BOLUSES. IT WAS STATED THAT THE INSULIN PUMP WAS NOT DROPPED OR BUMPED. THE ALARM HISTORY WAS REVIEWED, AND SEVERAL NO DELIVERY ALARMS WERE SEEN IN THE HISTORY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300089 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LWWS

    Patients

    Seq Age Sex Outcome Treatment
    1