BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4896248 · Received July 7, 2015

    Report

    Report Number
    3004209178-2015-71853
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Date of Event
    June 15, 2015
    Report Date
    June 16, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP FUNCTIONED PROPERLY DURING THE REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY ALARM TEST AND DISPLACEMENT TEST. NO MOTOR ERROR ALARM WAS NOTED. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING A BOLUS ATTEMPT. THE CUSTOMER WAS ADVISED TO REWIND THE INSULIN PUMP, AND THE ALARM DID NOT RECUR DURING THE REWIND STEP. THE CUSTOMER WAS ADVISED TO CHANGE THE SITES AND INFUSION SET. THE CUSTOMER CALLED AND REPORTED THAT THE MOTOR ERROR ALARM RECURRED DURING A BOLUS. THE CUSTOMER'S BLOOD GLUCOSE WAS 159 MG/DL. THE CALLER WAS ADVISED TO REPLACE THE INSULIN PUMP AND A REQUEST WAS MADE TO HAVE THE DEVICE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439798 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754LCAL

    Patients

    Seq Age Sex Outcome Treatment
    1