BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4240391 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49661
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 11, 2014
    Report Date
    October 11, 2014
    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

    NO UNEXPECTED RESETS NOTED DURING TESTING. THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND AND BASIC OCCLUSION TESTS. THE MOTOR ERROR ALARMED DURING PRIME TEST DUE TO MOISTURE DAMAGE ON MOTOR ASSEMBLY. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW, CRACKED CASE AT LCD WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, SCRATCHES ON RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS AND MISSING END CAP STICKER.

    Additional Manufacturer Narrative · 1

    (B)(4).CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP JUST STOPPED WORKING AND IT ALARMED MOTOR ERROR. CUSTOMER DID SELF TEST AND DEVICE STILL ALARMED. CUSTOMER'S BLOOD GLUCOSE WAS 220 MG/DL. ALARM OCCURRED DURING BOLUS DELIVERY THE FIRST TIME AND THEN IT OCCURRED WHEN FILLING TUBING. THE DEVICE RESET IT SELF AND CUSTOMER HAD RESET BASAL RATES AND TIME. THE DEVICE WAS NOT EXPOSED TO MRI. ALARM WAS CLEARED. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE DEVICE. CUSTOMER DOES NOT USE THE SENSOR FEATURE. CUSTOMER WAS UNABLE TO COMPLETE THE REWIND SEQUENCE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722452 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR