BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4141711 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33282
    Event Type
    Injury
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS, EXCESSIVE NO DELIVERY ALARMS, AND A LOW RESERVOIR ALARM ON THE INSULIN PUMP. CUSTOMER STATED THAT HIS BLOOD GLUCOSE WENT OVER 600 MG/DL AND HE CHANGED TO A NEW SITE AND HE CHANGED TO A NEW INFUSION SET. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS CURRENTLY 345 MG/DL. CUSTOMER TREATED WITH THE PUMP AND DID A BOLUS. CUSTOMER HAD NO SYMPTOMS OF HIGH BLOOD GLUCOSE LEVELS. CUSTOMER WAS ASSISTED WITH REMOVING THE RESERVOIR AND REWINDING THE PUMP. INSULIN EXITED AND PUMP SETTINGS WERE REVIEWED AND FOUND TO BE CORRECT. CUSTOMER DID NOT HAVE A TUBING CLAMP AND WILL NEED TO CALL BACK TO CONTINUE TROUBLESHOOTING ONCE HE RECEIVES THE TUBING CLAMP. CUSTOMER WAS ADVISED TO CHANGE THE ENTIRE SET, RESERVOIR, AND INSULIN. CUSTOMER WAS ALSO ADVISED TO TREAT PER HEALTH CARE PROFESSIONAL'S INSTRUCTION. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621286 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR