BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3945569 · Received July 21, 2014

    Report

    Report Number
    3004209178-2014-87914
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM NOTED. INSULIN PUMP ALSO RECEIVED WITH CRACKED CASE ON DISPLAY WINDOW CORNERS, MINOR SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE LIP, AND CRACKED BATTERY TUBE THREADS

    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

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER'S BLOOD GLUCOSE WAS 180 MG/DL. THE CUSTOMER TRIED TAKING THE BATTERY OUT AND PUTTING IT BACK IN, BUT THIS DID NOT SOLVE THE ISSUE. THEY WERE ADVISED TO TAKE THE BATTERY OUT OF THE DEVICE AS IT WAS STILL ALARMING. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424700 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR