BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4103105 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26416
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    May 13, 2014
    Report Date
    August 26, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS MONITORED FOR 48 HOURS WITH MULTIPLE BASAL RATE. NO BLACK DOT OR BLANK DISPLAY ANOMALY NOTED. ALL OPERATING CURRENTS WERE NORMAL. THE INSULIN PUMP WAS RECEIVED WITH CRACKED RESERVOIR TUBE. NO DAMAGE INSIDE PUMP NOTED. 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 THE INSULIN PUMP WAS DROPPED AND THAT THE SCREEN HAD GONE BLANK. THE BATTERY WAS REPLACED, BUT THE INSULIN PUMP WOULD NOT TURN ON. THE BLOOD GLUCOSE READING WAS 5.7 MMOL/L. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582688 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754WWS

    Patients

    Seq Age Sex Outcome Treatment
    1