BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4221605 · Received November 3, 2014

    Report

    Report Number
    2032227-2014-46570
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISPLACEMENT TEST COULD NOT BE PERFORMED DUE TO AN UNRESPONSIVE KEYPAD. THE INSULIN PUMP HAD AN UNRESPONSIVE ACT BUTTON DUE TO CORRODED KEYPAD TRACES. NO UNEXPECTED BUTTON ERROR ALARM WAS NOTED. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE, SCRATCHED RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS, A CRACKED BELT CLIP SLOT, A STAINED END CAP STICKER AND A STAINED ADDRESS AND SERIAL NUMBER LABEL.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A BUTTON ERROR ALARM ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 137 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702795 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR