BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4123755 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-07340
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    July 12, 2014
    Report Date
    July 12, 2014
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED FOR A BUTTON ERROR DUE TO CORRODED KEYPAD TRACES. NO MOISTURE DAMAGE WAS NOTED ON THE ELECTRONICS. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, AND A CRACKED RESERVOIR TUBE LIP.

    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 A BUTTON ERROR ON THE INSULIN PUMP. SHE STATED THAT SHE HAD GONE SWIMMING, REMOVED THE RESERVOIR AND LEFT THE TUBING CONNECTED UNDER THE BATHING SUIT. THE BLOOD GLUCOSE READING WAS NOT GIVEN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602915 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR