BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3160663 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-94565
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT TEST. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE OF 321MG/DL AFTER BOLUSING FOR HIS COFFEE. THE CUSTOMER STATED THAT LATER IN THE DAY, HIS GLUCOSE WAS 318MG/DL BEFORE DINNER, AND IT WAS 322MG/DL AFTER DINNER. HE STATED THAT HE WAS IN THE POOL THE DAY BEFORE AND FORGOT TO SUSPEND THE DEVICE. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. REVIEWED THE ALARM HISTORY AND FOUND LOW RESERVOIR ALARMS IN THE PAST FIVE DAYS. ASSISTED THE CALLER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. DURING THE CALL, THE CUSTOMER STATED THAT THE INSULIN PUMP IS UNDER-DELIVERING. WHILE TROUBLESHOOTING NOTICED THAT THE BOLUSES PROGRAMMED DID NOT MATCH WITH THE AMOUNT THE DEVICE INDICATES IT BOLUSED. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260587 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 62 YR