BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3801219 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-84452
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    March 25, 2014
    Report Date
    April 25, 2014
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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 CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, AND 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 ALARMED WHILE ATTEMPTING TO PRIME. THE CUSTOMER CHANGED THE RESERVOIR AND TRIED TO PRIME SEVERAL TIMES WITH THE SAME RESULTS. THE BLOOD GLUCOSE READING WAS 12.0MMOL/L. THE CALLER ALSO MENTIONED THAT INSULIN SQUIRTED OUT DURING THE MANUAL PRIME PROCESS, AND THE DEVICE WAS STUCK ON THE PRIME LOOP. ADVISED THE CUSTOMER THAT THE DEVICE WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278591 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-554WWL

    Patients

    Seq Age Sex Outcome Treatment
    1