BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4791017 · Received May 22, 2015

    Report

    Report Number
    3004209178-2015-59075
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 4, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY ALARM AND DISPLACEMENT TEST. NO MOTOR ERROR ALARM. THE MOTOR PASSED MOTOR TEST. NO BUTTON ERROR ALARM. THE INSULIN PUMP HAD AN INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE KEYPAD TRACE. THE INSULIN PUMP HAD MINOR SCRATCHED LCD WINDOW, CRACKED CASE NEAR DISPLAY WINDOW CORNERS AND CRACKED RESERVOIR TUBE LIP. NO ALARM ON ALARM HISTORY SCREEN.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER'S BLOOD GLUCOSE WAS 6.5 MMOL/L. THE CUSTOMER. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT DROPPED AND THAT THEY DID NOT RECEIVE THE MOTOR POSITION ENCODER ERROR ALARM. THE CUSTOMER FURTHER STATED THAT THEY RECEIVED A BUTTON ERROR ALARM A WEEK PRIOR TO THE MOTOR ERROR ALARM. THE CUSTOMER WAS ADVISED THAT A REPLACEMENT INSULIN PUMP WOULD BE SENT. THE CUSTOMER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335704 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWP

    Patients

    Seq Age Sex Outcome Treatment
    1