BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4241222 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50076
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    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. HOWEVER, THE HAD MINOR SCRATCHES ON THE LCD WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, A CRACKED BELT CLIP SLOT AT THE BATTERY TUBE THREADS AREA, AND A CRACKED RESERVOIR TUBE LIP. NO CRACKS ON THE LCD DISPLAY WINDOW OR LCD GLASS NOTED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 154 MG/DL. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAS A CRACK ON THE SCREEN. IT WAS REPORTED THAT THE CRACK ON THE DISPLAY OF THE INSULIN WAS MAKING IT DIFFICULT TO READ THE INFORMATION ON THE DISPLAY OF THE INSULIN PUMP. THE CUSTOMER ALSO REPORTED A MOTOR ERROR ALARM FROM THE INSULIN PUMP DURING BASAL. TROUBLESHOOTING WAS DONE. IT WAS REPORTED THAT THE CUSTOMER WAS NOT USING THE SENSOR FEATURE OF THE INSULIN PUMP. THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT EXPOSED TO ANY STRONG MAGNETIC FIELD. THE CUSTOMER WAS ABLE TO COMPLETE THE REWIND SEQUENCE ON THE INSULIN PUMP. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK-UP PLAN PER THE HEALTH CARE PROVIDER'S INSTRUCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724040 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR