BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103610 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25338
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM, FROZEN SCREEN, NOR MOISTURE DAMAGE INSIDE THE INSULIN PUMP WAS FOUND. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR, WAS UNRESPONSIVE TO BUTTON PRESSES, AND HAD A FROZEN SCREEN. THE BLOOD GLUCOSE READING WAS 120 MG/DL. THE CUSTOMER'S MOTHER STATED THAT THE INSULIN PUMP HAD BEEN EXPOSED TO WATER, BUT SHE MENTIONED THAT IT HAD BEEN SPLASHED, NOT SUBMERGED. THE CUSTOMER CALLED ANOTHER TIME, REPORTING A BUTTON ERROR ALARM WHICH OCCURRED DURING A BOLUS ATTEMPT. THE BLOOD GLUCOSE READING WAS 68 MG/DL. ADVISED REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582295 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR