BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4130553 · Received September 30, 2014

    Report

    Report Number
    3004209178-2014-95971
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS WERE NOTED. NO NUMBER RAMPING WAS NOTED ON THE DISPLAY. NO TRACES OF MOISTURE WERE NOTED AT THE ELECTRONIC OR MOTOR ASSEMBLIES PER VISUAL INSPECTION. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNERS AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BUTTON ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS 341 MG/DL. THE CUSTOMER TREATED HER HIGH BLOOD GLUCOSE WITH A MANUAL INJECTION. THE CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE ALARM. CUSTOMER ALSO DECLINED TO TROUBLESHOOT. CUSTOMER IS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609604 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR