BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4143725 · Received October 6, 2014

    Report

    Report Number
    2032227-2014-30562
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE INSULIN PUMP WAS RECEIVED WITH CRACKED RESERVOIR TUBE LIP NOTED DURING VISUAL INSPECTION. PUMP WAS MONITORED. NO A47 ALARMS NOTED. HOWEVER A47 ALARM NOTED IN ALARM HISTORY DUE TO CORRUPTED HISTORY FILE.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 CUSTOMER HAD A DISPLAYABLE HISTORY CHECK FAILED ON STARTUP ALARM ON THE INSULIN PUMP. CUSTOMER STATED THAT THE ALARM OCCURRED 8 TIMES IN ONE DAY. INSULIN PUMP WILL BE RETURNED AND REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624679 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754WWL

    Patients

    Seq Age Sex Outcome Treatment
    1