BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3961413 · Received July 28, 2014

    Report

    Report Number
    2032227-2014-04830
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH CRACKED DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS AND RESERVOIR TUBE LIP. THE DEVICE WAS UNABLE TO PRIME DURING THE PRIME TEST AND ALARMED DURING THE BASIC OCCLUSION TEST DUE TO A PROTRUDED/LOOSE DRIVE SUPPORT DISK. IT WAS ALSO NOTED THAT THE INSULIN PUMP HAD A SCRATCHED LCD WINDOW, BROKEN BELT CLIP SLOT AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD A PRIME/FILL ANOMALY AND THE CUSTOMER REQUESTED TO RETURN THE DEVICE FOR ANALYSIS. THE BLOOD GLUCOSE READING WAS NOT PROVIDED. THE CUSTOMER STATED THAT THE INSULIN PUMP DELIVERED A LARGE AMOUNT OF INSULIN IMMEDIATELY AFTER SET CHANGE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437394 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-715LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1