BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4003684 · Received August 12, 2014

    Report

    Report Number
    3004209178-2014-92752
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE INSULIN PUMP PASSED FUNCTIONAL TEST INCLUDING PRIME, DISPLACEMENT, BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TESTS. NO UNEXPECTED BATTERY OUT LIMIT ALARMS NOTED. NO COSMETIC DAMAGE NOTED ON PUMP. LOW RESERVOIR ALARM FUNCTION PROPERLY DURING TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEY DO NOT BELIEVE THEIR INSULIN PUMP IS FUNCTIONING PROPERLY. CUSTOMER STATES THEIR BLOOD GLUCOSE LEVELS HAD BEEN INCREASING OVER 500 MG/DL AND THE DEVICE FAILED TO ALARM LOW RESERVOIR. CUSTOMER WAS ADVISED TO DISCONNECT FROM DEVICE. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED TO CHECK THE CONDITION OF THE DRIVE SUPPORT CAP ON THE DEVICE AND FOUND IT TO BE NORMAL. NEXT, CUSTOMER WAS ASKED TO CHECK FOR AIR BUBBLES IN INFUSION SET TUBING. CUSTOMER VERIFIED THERE WERE NO AIR BUBBLES. AFTERWARDS, THE RESERVOIR WAS REINSERTED INTO INSULIN PUMP AND A MANUAL PRIME WAS PERFORMED. INSULIN PUMP DID NOT ALARM AND CUSTOMER WAS ADVISED THE DEVICE WAS FUNCTIONING PROPERLY. BLOOD GLUCOSE LEVEL WAS 230 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477819 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR