BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4014233 · Received August 18, 2014

    Report

    Report Number
    3004209178-2014-94210
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    July 5, 2014
    Report Date
    February 22, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE FUNCTIONAL TEST, INCLUDING SELF-TEST, UNEXPECTED RESTART ERROR TEST, DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, OFF NO POWER TEST AND EXCESSIVE NO DELIVERY TEST. DEVICE WAS MONITORED FOR 24 HOURS, NO BLANK DISPLAY OR FAILED BATTERY TEST ALARM NOTED. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. NO UNEXPECTED LOW BATTERY OR OFF NO POWER ALARMS NOTED. NO CONNECTOR ISOLATED TAPE DAMAGE NOTED ON LCD BOARD. DEVICE RECEIVED WITHOUT BATTERY CAP AND BELT CLIP UNABLE TO CONFIRM DAMAGE. UNIT RECEIVED WITH CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE WINDOW, CRACKED CASE AT RESERVOIR TUBE WINDOW CORNER.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER'S INSULIN PUMP SHUT OFF BY ITSELF. CUSTOMER CHANGED THE BATTERY AND THE DEVICE KEPT ALARMING FAILED BATTERY TEST. CUSTOMER TRIED NEW BATTERIES FROM DIFFERENT PACKAGES. CUSTOMER'S BLOOD GLUCOSE IS 12.0 MMOL/L. THE BATTERY CAP AND CONTACTS ARE NOT DAMAGED OR CORRODED. CUSTOMER CLEANED THE CAP AND CONTACTS WITH ALCOHOL. CUSTOMER INSERTED A NEW BATTERY, AND THERE WAS NO FAILED BATTERY TEST ALERT. CUSTOMER WANTED A REPLACEMENT DEVICE BECAUSE SHE FELT UNCOMFORTABLE USING HER CURRENT DEVICE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492980 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554CML

    Patients

    Seq Age Sex Outcome Treatment
    1