BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4223340 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-46777
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 5, 2014
    Report Date
    October 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME TEST DUE TO FAULTY FORCE SENSOR. MOTOR TESTED OUTSIDE DEVICE AND PASSED. NO MOTOR ERROR ALARM NOTED. NO EXCESSIVE NO DELIVERY ALARM NOTED. INSULIN PUMP HAD MINOR SCRATCHES ON LCD WINDOW, CRACKED CASE NEAR LCD WINDOW CORNER, CRACKED RESERVOIR TUBE, SCRATCHED RESERVOIR TUBE WINDOW, CRACKED RESERVOIR TUBE LIP, BROKEN BATTERY TUBE THREADS, STAINED ADDRESS/SERIAL NUMBER LABEL AND MISSING END CAP STICKER.

    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 140 MG/DL. THE CUSTOMER REPORTED A MOTOR ERROR FROM THE INSULIN PUMP DURING BOLUS. THE CUSTOMER ALSO REPORTED A NO DELIVERY ALARM FROM THE INSULIN PUMP. TROUBLESHOOTING WAS DONE. THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT EXPOSED TO ANY STRONG MAGNETIC FIELD. THE CUSTOMER WAS ABLE TO REWIND 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
    708333 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR