BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4123209 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-28866
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER

    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 WAS MONITORED FOR FOUR DAYS WITH NO UNEXPECTED BUTTON ERROR ALARMS. THE INSULIN PUMP PASSED OPERATING CURRENTS TESTS. ALL BUTTONS FUNCTIONED PROPERLY. HOWEVER, CORRODED KEYPAD TRACES WERE NOTED DURING THE VISUAL INSPECTION. NO UNEXPECTED BATTERY OUT LIMIT ALARMS WERE NOTED. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, SCRATCHED RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS AND A STAINED END CAP STICKER. MOISTURE DAMAGE WAS NOTED ON ALL ELECTRONIC ASSEMBLIES. A SLIGHTLY CORRODED BATTERY TUBE WAS NOTED. CORRODED MOTOR HOME SWITCH TRACES AND MOTOR FLEX CABLE FINGERS WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. IT WAS ALSO REPORTED THAT INSULIN PUMP WAS EXPOSED TO MOISTURE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT INCLUDED IN THE REPORT.. 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
    602686 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR