BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3942377 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87581
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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 RECEIVED WITH INTERMITTENT BUTTON RESPONSE AND BUTTON ERROR ALARM DUE TO CORRODED KEYPAD TRACES. THE INSULIN PUMP HAD NORMAL OPERATING CURRENTS AND NO UNEXPECTED OFF/NO POWER, LOW BATTERY OR BATTERY OUT LIMIT ALARM NOTED. THE INSULIN PUMP HAD MINOR SCRATCHED LCD WINDOW, CRACKED DISPLAY WINDOW CORNER AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR DURING THE BOLUS PROCEDURE. THE CUSTOMER WAS OFF THE DEVICE FOR ONE WEEK AND TREATED WITH MANUAL INJECTION SINCE THEN. THE BLOOD GLUCOSE READING WAS 189 MG/DL. THE CUSTOMER STOPPED TO TEST HER BLOOD GLUCOSE LEVEL DURING THE CALL AND THE READING WAS 239 MG/DL. SHE ATTEMPTED TO RESOLVED THE ISSUE BY REPLACING THE BATTERY BUT THIS DID NOT SOLVE THE PROBLEM. NO SIGNIFICANT EVENTS LEADING TO THE ALARM WERE OBSERVED. ADVISED DISCONTINUATION OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419482 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR