BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4192932 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41351
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER

    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 THAT THE CUSTOMER HAS BEEN EXPERIENCING ISSUES WITH HIS INSULIN PUMP. HE ALSO REPORTED TO BE EXPERIENCING HIGH BLOOD GLUCOSE LEVELS. HE REPORTED HIS BLOOD GLUCOSE LEVEL TO BE 355 MG/DL. THE CUSTOMER CHECKED HIS INFUSION SET AND THE INSULIN PUMP HAD NOT BEEN GIVING ANY ALARMS. HE REPORTED THAT AFTER INSERTING A NEW SET HIS INSULIN PUMP SEEMED TO NOT BE WORKING BECAUSE HIS BLOOD GLUCOSE LEVELS WERE NOT COMING DOWN. THEREFORE, HE GAVE HIMSELF A MANUAL INSULIN INJECTION TO HELP LOWER HIS BLOOD GLUCOSE LEVELS. TROUBLESHOOTING WAS ADVISED BUT UNABLE TO BE COMPLETED AT THE TIME OF THE REPORT. THE PRODUCT IS NOT BEING RETURNED. NOTHING FURTHER TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673663 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR