BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4243982 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50812
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    March 28, 2014
    Report Date
    October 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).INSULIN PUMP RECEIVED WITH HIGH IDLE CURRENT DUE TO OPEN LCD DRIVER ON LCD BOARD. DEVICE RECEIVED WITH CRACKED RESERVOIR TUBE LIP.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 CUSTOMER RECEIVED LOW BATTERY ALERTS TWICE AFTER RECEIVING A BATTERY CAP REPLACEMENT. CUSTOMER HAD USED 11 BATTERIESWITHIN 30 DAYS. CUSTOMER DOES NOT USE THE SENSOR FEATURE AND IS USING NEW BATTERIES. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726155 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWS

    Patients

    Seq Age Sex Outcome Treatment
    1