BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3223124 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-95598
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 8, 2013
    Report Date
    June 21, 2013
    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 FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST AND ALARMED MOTOR ERROR DURING THE BASIC OCCLUSION TEST AS A RESULT OF A LOOSE DRIVE SUPPORT DISK. THE MOTOR WAS TESTED OUTSIDE THE UNIT AND PASSED. THE DEVICE FAILED TO VIBRATE DURING THE SELF TEST DUE TO BROKEN WIRE AT THE VIBRATOR MOTOR. THE UNIT WAS RECEIVED WITH SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP WAS ALARMING MOTOR ERROR FOR THE PAST TWO DAYS. THE CUSTOMER'S BLOOD GLUCOSE WAS 230MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. ASSISTED THE MOTHER TO RUN THE DISPLACEMENT TEST AND PASSED. THE SELF TEST WAS PERFORMED AND FAILED. THE MOTHER STATED THAT THE DEVICE HAS NOT VIBRATED FOR OVER A YEAR. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321525 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 15 YR