BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3971923 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88591
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A33 ALARM DURING PRIME/A33 TEST AT 4.0 LBS DUE TO FAULTY FSR (GOLD) AND MOTOR ERROR ALARM DURING BASIC OCCLUSION TEST DUE TO FAULTY FSR (GOLD). MOTOR PASSED MOTOR TEST.PUMP RECEIVED WITH SCRATCHED LCD WINDOW, CRACKED CASE DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE WINDOW AND A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED DURING THE MANUAL PRIME. CUSTOMER ALSO REPORTED A MOTOR ERROR ALARM DURING BASAL. CUSTOMER STATED THAT THE INSULIN PUMP WAS DROPPED. TROUBLESHOOTING WAS PERFORMED AND THE DRIVE SUPPORT CAP APPEARED TO BE NORMAL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446953 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR