BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5002363 · Received August 13, 2015

    Report

    Report Number
    2032227-2015-29345
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    January 24, 2015
    Report Date
    July 23, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT PASSED THE REWIND, BASIC OCCLUSION TEST, PRIME/DELIVERY TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. HOWEVER, UNIT ALARMED MOTOR ERROR DURING OCCLUSION TEST DUE TO FAULTY BACK PRESSURE SENSOR (GOLD). THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. UNIT WAS RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS. UNIT WAS RECEIVED WITH MINOR SCRATCHED LCD WINDOW. UNIT WAS RECEIVED WITH STAINED END CAP STICKER. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HIS INSULIN PUMP ALARMED MOTOR ERROR DURING A BOLUS ATTEMPT. CUSTOMER DOES NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE ERROR. CUSTOMER'S BLOOD GLUCOSE WAS 278 MG/DL AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS ATTEMPTED FOR THE MOTOR ERROR AND CUSTOMER WAS ABLE TO COMPLETE THE REWIND SEQUENCE HOWEVER, CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN PER DOCTOR'S INSTRUCTION. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532706 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 30 YR