BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4062077 · Received September 4, 2014

    Report

    Report Number
    2032227-2014-17203
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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. 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. 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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, COMPROMISED FORCE SENSOR AND EXCESSIVE NO DELIVERY TEST. THERE WAS NO MOTOR ERROR OR EXCESSIVE NO DELIVERY ALARM NOTED. THE MOTOR PASSED THE MOTOR TEST. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE AND BROKEN BELT CLIP SLOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER HAD A NO DELIVERY ALARM. WHILE ATTEMPTING TO CHANGE THEIR INFUSION SET, THE CUSTOMER ALSO RECEIVED A MOTOR ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER ALSO STATED THE MOTOR ERROR ALARMED OCCURRED DURING A BASAL DELIVERY. THE CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE ALARM. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541707 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754LWWP

    Patients

    Seq Age Sex Outcome Treatment
    1