BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4211856 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44888
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. SEE MEDWATCH: 2032227-2014-44898.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A CUSTOMER RECEIVED AN ERROR ALARM ON THEIR INSULIN PUMP. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE CALL. THE CUSTOMER STATED THAT THEY ARE BLIND AND CAN NOT READ WHAT THE ALARM VIBRATION WAS ABOUT. THE CUSTOMER STATED THAT SHE IS TRYING TO FIND A NEIGHBOR ORE SOMEONE ONE THAT CAN HELP READ THE INSULIN PUMP. IT IS UNCERTAIN IF THE ISSUE IS RELATED TO A BUTTON ERROR. SO THE CUSTOMER WILL CALL BACK ONCE SHE HAS FOUND SOMEONE TO HELP READ THE PUMP. THE CUSTOMER HAD ALSO MENTIONED THAT THERE WAS A HOSPITALIZATION VISIT ON (B)(6) 2014 AT 5:45 AM FOR A BLOOD GLUCOSE LEVEL OF 495 MG/DL AND DIABETES KETOACIDOSIS. THE CUSTOMER EXPERIENCED THE FOLLOWING SYMPTOMS OF HIGH BLOOD GLUCOSE LEVELS: HYPERVENTILATING, VOMITING, AND PAIN. THE CUSTOMER DID NOT KNOW SHE HAD USED EXPIRED INSULIN AND THAT CAUSED HER HOSPITALIZATION. SHE WAS TREATED WITH AN IV AND INSULIN DRIP. SHE WAS WEARING HER INSULIN PUMP AT THE TIME OF HER HOSPITALIZATION. TROUBLESHOOTING WAS DEC...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693903 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR