BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3191782 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-95067
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    February 7, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH CURRENTS WITHIN SPECIFICATIONS. THE DEVICE WAS UNABLE TO PRIME DURING THE PRIME TEST AS A RESULT OF A PROTRUDED/LOOSE DRIVE SUPPORT DISK. HOWEVER, THE MOTOR PASSED THE MOTOR TEST. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE PRIME ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP ALARMED MOTOR ERROR DURING PRIME. THE BLOOD GLUCOSE READING WAS 24MMOL/L. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. ASSISTED THE CALLER TO RUN A DISPLACEMENT AND SELF TEST AND THEY PASSED. MORE THAN A MOTH LATER, THE CUSTOMER CALLED BACK TO REPORT GETTING NO DELIVERY ALARMS TWO TO THREE TIMES ALONG WITH THE MOTOR ERRORS. IT WAS STATED THAT IT APPEARS THIS HAPPENS MORE OFTEN AS THE INSULIN IN THE RESERVOIR IS REDUCED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290485 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722CAS

    Patients

    Seq Age Sex Outcome Treatment
    1