BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3820289 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-84827
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    February 27, 2014
    Report Date
    May 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED DURING THE BASIC OCCLUSION TEST AS A RESULT OF A PROTRUDED/LOOSE DRIVE SUPPORT DISK. THE DEVICE WAS RECEIVED WITH SCRATCHED SCREEN, CRACKED CASE DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING ISSUES WITH THE INSULIN PUMP. THE DEVICE ALARMED WHILE ATTEMPTING TO CHANGE THE INFUSION SET. THE BLOOD GLUCOSE READING WAS 120MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300477 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR