BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4161933 · Received October 10, 2014

    Report

    Report Number
    2032227-2014-36131
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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

    CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 479 MG/DL. SHE ALSO REPORTED BEING THIRSTY AS A SYMPTOM OF HER HIGH BLOOD GLUCOSE. THE CUSTOMER STATED SHE HAD TREATED HER BLOOD GLUCOSE WITH AN INJECTION. TROUBLESHOOTING FOUND INSULIN WAS ABLE TO EXIT FROM THE TUBING DURING A MANUAL PRIME. THERE WAS ALSO NO LEAKS FOUND ON THE CUSTOMER'S INSULIN PUMP AND THERE WAS NO BENT CANNULA. THE CUSTOMER WAS ADVISED TO CONTACT HER HEALTHCARE PROVIDER. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643661 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR