BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4244002 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50752
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH NO UP BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES, MOISTURE DAMAGE ON THE ELECTRONICS, VIBRATOR AND BATTERY TUBE ASSEMBLY. NO MOISTURE DAMAGE ON THE MOTOR ASSEMBLY NOTED. THE INSULIN PUMP WAS RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, SCRATCHED RESERVOIR TUBE WINDOW AND MINOR SCRATCHED LIQUID CRYSTAL DISPLAY WINDOW.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH NO UP BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES, MOISTURE DAMAGE ON THE ELECTRONICS, VIBRATOR AND BATTERY TUBE ASSEMBLY. NO MOISTURE DAMAGE ON THE MOTOR ASSEMBLY NOTED. THE INSULIN PUMP WAS RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, SCRATCHED RESERVOIR TUBE WINDOW AND MINOR SCRATCHED LIQUID CRYSTAL DISPLAY WINDOW.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTED THAT THE INSULIN PUMP HAD VISIBLE MOISTURE UNDER THE DISPLAY SCREEN. CALLER REPORTED THAT THE INSULIN PUMP WAS RECENTLY EXPOSED TO SWEAT. BLOOD GLUCOSE LEVEL WAS 250 MG/DL AT THE TIME OF THE CALL. CUSTOMER TREATED WITH A MANUAL INSULIN INJECTION. CALLER REPORTED THAT THE INSULIN PUMP'S KEYPAD WAS NOT RESPONDING PROPERLY. CALLER REPORTED PUSHING ALL OF THE BUTTONS TO ESCAPE THE RESERVOIR SETUP SCREEN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725738 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR