BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4142298 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33463
    Event Type
    Malfunction
    Date Received
    October 5, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION TEST, PRIME TEST AND DISPLACEMENT TEST. INSULIN PUMP RECEIVED STUCK IN THE MOTOR ERROR LOOP DURING BOLUS AND BASAL DELIVERY. UNABLE TO CONFIRMED ERROR ALARM DUE TO ERASED HISTORY FILE. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUR TESTING. INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON RESERVOIR TUBE WINDOW.

    Additional Manufacturer Narrative · 1

    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. 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP RETURNED A MOTOR ERROR ALARM DURING PRIMING. CUSTOMER DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING UP TO THE ERROR ALARM. REVIEW OF THE INSULIN PUMP'S ALARM HISTORY SHOWED THAT AN ADDITIONAL ERROR ALARM WAS RETURNED. BLOOD GLUCOSE LEVEL WAS 127.8 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621860 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754CMP

    Patients

    Seq Age Sex Outcome Treatment
    1