BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4780906 · Received May 19, 2015

    Report

    Report Number
    3004209178-2015-57559
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 28, 2015
    Report Date
    April 28, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP EXPERIENCED A DELIVERY ANOMALY. THE CUSTOMER'S BLOOD GLUCOSE WAS 20 MMOL/L AND THE CUSTOMER HAD A PRESENCE OF KETONES. THE CUSTOMER'S MOTHER STATED THAT THE INSULIN PUMP ALARMED NO DELIVERY. THE CUSTOMER'S MOTHER STATED THAT THE BOLUS HAD BEEN TRICKY, AS IT SEEMED AS THOUGH THE BOLUS WAS NOT DELIVERING CORRECTLY. SHE STATED THAT THERE WAS AN ABSENCE OF NO DELIVERY ALARMS DURING BOLUSES, SINCE THE CUSTOMER EXPERIENCED UNEXPLAINED HIGH BLOOD GLUCOSE. THE CUSTOMER'S MOTHER DECLINED TROUBLESHOOTING ASSISTANCE, AS SHE HAD DONE TROUBLESHOOTING ON HER OWN. 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
    326437 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554CAP

    Patients

    Seq Age Sex Outcome Treatment
    1