BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4170466 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37981
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED FUNCTIONAL TESTING INCLUDING DISPLACEMENT, REWIND, BASIC OCCLUSION, PRIME/A33 AND NO DELIVERY TESTS. NO EXCESSIVE NO DELIVERY ALARM NOTED. THE INSULIN PUMP WAS RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNER AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 7 MMOL/L. THE CUSTOMER REPORTED A NO DELIVERY ALARM FROM THE INSULIN PUMP DURING REWIND AND BOLUS. TROUBLESHOOTING WAS DONE. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD NEED TO BE RETURNED FOR ANALYSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651024 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWB

    Patients

    Seq Age Sex Outcome Treatment
    1