BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4190992 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41199
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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 PRIME DURING THE BASIC OCCLUSION TEST DUE TO LOOSE/PROTRUDED DRIVE SUPPORT DISK. THE INSULIN PUMP WAS UNABLE TO PERFORM REWIND TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST OR VERIFY MOTOR ERROR ALARM DUE TO PRIME ALARM. THE MOTOR WAS TESTED OUTSIDE OF THE INSULIN PUMP AND PASSED. THE INSULIN PUMP HAD MINOR SCRATCHES ON LCD WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, BROKEN BELT CLIP SLOT, CRACKED RESERVOIR TUBE LIP AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR AND HAD LOOSE DRIVE SUPPORT. CUSTOMER'S MOTHER STATED THAT PATIENT'S INSULIN PUMP ALARMED MOTOR ERROR AND DRIVE SUPPORT CAP WAS BEING PUSHED OUT. CUSTOMER WAS DOING A SET CHANGE AND GOT MOTOR ERROR ALARM. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 7.6 MMOL/L. ADVISED CUSTOMER THE INSULIN PUMP WOULD BE REPLACED. ADVISED TO DISCONTINUE USING THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROVIDER. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670107 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWS

    Patients

    Seq Age Sex Outcome Treatment
    1