BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 6044372 · Received October 20, 2016

    Report

    Report Number
    2032227-2016-33469
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    September 29, 2016
    Report Date
    December 13, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED MOTOR ERROR DURING REWIND DUE TO MOTOR ENCODER SIGNAL OUT OF PHASE. WE WERE UNABLE TO PERFORM SELF-TEST, OFF NO POWER TEST, ERROR TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST, DISPLACEMENT TEST DUE TO MOTOR ERROR ALARM. THE INSULIN PUMP PASSED IDLE CURRENT TEST AND RUN CURRENT TEST. WE WERE UNABLE TO VERIFY ALARM DUE TO MOTOR ERROR ALARM. THE INSULIN PUMP WAS RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE ALARMED MOTION SENSOR TEST FAILED ALARM. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. DEVICE DID NOT PASS THE DISPLACEMENT TEST. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONALS' INSTRUCTIONS. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. CUSTOMER AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696797 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWL

    Patients

    Seq Age Sex Outcome Treatment
    1