BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4142182 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33379
    Event Type
    Malfunction
    Date Received
    October 5, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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). REFERENCE MANUFACTURER REPORT NUMBER: 2032227-2014-33380.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER HAD CONCERNS ABOUT HIS HIGH BLOOD GLUCOSE. HE ALSO REPORTED HE HAD A BOLUS DELIVERY THAT WAS NOT RECORDED IN THE INSULIN PUMP. THE CALLER ALSO REPORTED THAT THE ACT BUTTON MAY HAVE NOT BEEN PRESSED TO DELIVER THE BOLUS. A NO DELIVERY ALARM WAS ALSO FOUND IN THE ALARM HISTORY. IT WAS REPORTED THE NO DELIVERY ALARM WAS RESOLVED BY AN INFUSION SET CHANGE. THE CUSTOMER'S DRIVE SUPPORT CAP ALSO APPEARED TO BE NORMAL. THE CALLER WAS ALSO INQUIRING WHY THE CUSTOMER HAD A SUDDEN DROP OF BLOOD GLUCOSE FROM 281 MG/DL TO 112 MG/DL. THE CUSTOMER DID NOT RECALL ANY UNUSUAL EVENTS OCCURRING BESIDES HAVING A DIALYSIS RECENTLY. IT WAS ALSO FOUND THERE WAS AIR BUBBLES IN THE CUSTOMER'S RESERVOIR. THE CUSTOMER WAS ABLE TO GET RID OF THE AIR BUBBLES. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621882 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR