BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3141067 · Received June 3, 2013

    Report

    Report Number
    2032227-2013-02212
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    April 20, 2013
    Report Date
    May 22, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST AS A RESULT OF A LOOSE/PROTRUDED DRIVE SUPPORT DISK. THE DEVICE WAS RECEIVED WITH SCRATCHED DISPLAY WINDOW, CRACKED CASE AT THE SCREEN CORNERS, AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED REGARDING ISSUES DURING PRIME/REWIND. THE BLOOD GLUCOSE READING WAS 94MG/DL. THE CALLER STATED THAT THE INSULIN PUMP ALARMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. ADVISED THE CALLER TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244579 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR