BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4862642 · Received June 23, 2015

    Report

    Report Number
    3004209178-2015-67808
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    December 10, 2014
    Report Date
    June 4, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION, PRIME, AND DISPLACEMENT TEST. THE DEVICE WAS RECEIVED STUCK IN THE MOTOR ERROR ALARM LOOP DURING BOLUS DELIVERY. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND IT PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE RESPONDED THAT WASN'T DETECTED DURING TESTING. THE DEVICE HAD CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE LCD WINDOW, CRACKED LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW, AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE, THE INSULIN PUMP HAD ALARMED MOTOR ERROR BUT HE HAS TAKEN CARE OF THE ISSUES. CUSTOMER' BLOOD GLUCOSE WAS 260 MG/DL, TREATED WITH MANUAL INJECTION. CUSTOMER DOESN'T RECALL ANY SIGNIFICANT EVENTS WHICH MAY HAVE CAUSED THE DEVICE TO ALARM. THE DEVICE WAS NOT EXPOSED TO AN MRI AND CUSTOMER WAS ABLE TO COMPLETE THE REWIND PROCESS. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE, REVERT TO BACK UP PLAN, AND THE DEVICE NEED TO BE REPLACED. HE AGREED TO RETURN THE DEVICE FOR ANALYSIS. CUSTOMER STATED HE HAD A MOTOR FAILURE 30 AND HE WOKE UP WITH HIGH BLOOD GLUCOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407368 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR