BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4210581 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43324
    Event Type
    Injury
    Date Received
    October 25, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK 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

    CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 360 MG/DL. THE CUSTOMER ALSO STATED SHE WAS NOT HAVING SYMPTOMS OF HIGH BLOOD GLUCOSE. TROUBLESHOOTING FOUND THE CUSTOMER'S DRIVE SUPPORT CAP WAS NORMAL. THERE WAS ALSO NO AIR BUBBLES FOUND IN THE TUBING. INSULIN WAS ALSO ABLE TO EXIT THE TUBING DURING A MANUAL PRIME. CUSTOMER WAS UNABLE TO CHECK IF HER CANNULA WAS OCCLUDED. THE CUSTOMER WAS ADVISED TO CHANGE OUT HER INFUSION SET, RESERVOIR, AND INSULIN. NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680875 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR