BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4780952 · Received May 19, 2015

    Report

    Report Number
    2032227-2015-16114
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 25, 2014
    Report Date
    April 29, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A MOTOR ERROR ALARM DURING THE OCCLUSION TEST AND WAS UNABLE TO PRIME AT 4.0 LBS DURING THE PRIME TEST DUE TO A FAULTY FORCE SENSOR RESISTOR (GOLD). THE MOTOR PASSED THE MOTOR TEST. THE UNIT HAD A CRACKED CASE AT THE DISPLAY WINDOW CORNER, A MINOR SCRATCHED LIQUID CRYSTAL DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, BROKEN BELT CLIP SLOT AT THE BATTERY TUBE THREADS AREA, BROKEN RESERVOIR TUBE LIP, MISSING RESERVOIR TUBE O-RING AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MOTOR ERROR WHILE THE CUSTOMER WAS ADDING INSULIN TO THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS 172 MG/DL. THE CUSTOMER DID NOT OBSERVE ANY SIGNIFICANT EVENTS LEADING TO THE ALARM. THE CUSTOMER WAS UNABLE TO COMPLETE THE REWIND SEQUENCE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED TO REPLACE THE INSULIN PUMP AND AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326959 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR