BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4230700 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-26394
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER WAS ATTEMPTING A 5.9 UNIT CORRECTION WHEN HE RECEIVED A FINISHED LOADING ALARM. CUSTOMER'S BLOOD GLUCOSE WAS 500 MG/DL. HE STATED HE HAD TREATED HIS BLOOD GLUCOSE WITH A SYRINGE. WHILE ASSISTING THE CUSTOMER WITH CLEARING THE ALARM, IT WAS FOUND THE CUSTOMER HAD A PRIME/REWIND ANOMALY. CUSTOMER STATED HE WAS STUCK IN THE REWIND COMPLETE/BOLUS DELIVERY LOOP. CUSTOMER WAS ADVISED TO REMOVE HIS BATTERY. TROUBLESHOOTING WAS ABLE TO HELP THE CUSTOMER EXIT THE REWIND COMPLETE/BOLUS DELIVERY LOOP. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715409 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR