BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4192678 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41099
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO BUTTON ERROR ALARM WAS NOTED DURING TESTING. HOWEVER, THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, SCRATCHED RESERVOIR TUBE WINDOW AND A STAINED END CAP STICKER.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A BUTTON ERROR ALARM ON THE INSULIN PUMP AND STATED THAT THEY WERE UNABLE TO CLEAR IT. CUSTOMER STATED THAT THEY MAY HAVE SLEPT ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 170 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671088 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR