BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4240091 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49811
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    September 11, 2014
    Report Date
    October 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    INSULIN PUMP HAD AN INTERMITTENT BUTTON RESPONSE, DUE TO CORRODED EXPRESS BOLUS, ESC AND ACT BUTTON ON KEYPAD TRACES. NO BUTTON ERROR ALARM DURING TESTING. INSULIN PUMP HAD MINOR SCRATCHES ON LCD WINDOW, CRACKED CASE ON DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. CUSTOMER STATED THE INSULIN PUMP HAD PROBLEMS WITH BUTTONS AND NOW SHE GOT MOTOR ERROR. CUSTOMER DOES NOT RECALL HER BLOOD GLUCOSE. TROUBLESHOOTING WAS DONE. ADVISED CUSTOMER THE INSULIN PUMP WOULD BE REPLACED. ADVISED TO DISCONTINUE USING THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROVIDER. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723397 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR