BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183486 · Received October 18, 2014

    Report

    Report Number
    2032227-2014-40208
    Event Type
    Injury
    Date Received
    October 18, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PATIENT

    Narratives

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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 CHANGED HER INFUSION SETS, BUT HER BLOOD GLUCOSE LEVEL WERE STILL IN THE 300 OR 400 MG/DL RANGE. CUSTOMER DID NOT CONTACT HER HEALTH CARE PROFESSIONAL FOR HER HIGH BLOOD GLUCOSE LEVELS. CUSTOMER TREATED WITH THE PUMP. CUSTOMER RAN A MANUAL PRIME AND THE INSULIN DID EXIT FROM THE PUMP. THE TIME AND DATE ARE INCORRECT. CUSTOMER WAS ASSISTED WITH CORRECTING. THE ALARM HISTORY WAS REVIEWED AND A LOW RESERVOIR AND LOW BATTERY ALARMS WERE FOUND. BOLUSES WERE FOUND TO BE CORRECT AND ARE BEING RECORDED IN THE BOLUS HISTORY. CUSTOMER DOES NOT HAVE A TUBING CLAMP AVAILABLE. CUSTOMER WILL BE SENT A TUBING CLAMP AND WILL NEED TO CALL BACK ONCE SHE RECEIVES IT TO COMPLETE TROUBLESHOOTING. CUSTOMER CALLED BACK AND THE PUMP PASSED THE HIGH PRESSURE TEST. CUSTOMER STATED THAT THE CANNULA WAS BENT AFTER REMOVING THE SET FROM HER BODY. CUSTOMER WAS ADVISED TO SEND THE BENT CANNULA FOR ANALYSIS AND THAT THE PUMP WAS WORKING. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663852 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR