BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4240456 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49712
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD A BLANK DISPLAY DUE TO A BROKEN SOLDER JOINT ON THE INTERFACE BOARD. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNERS AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP STOPPED WORKING. SHE STATED SHE REPLACED THE BATTERY AND NOTHING CAME BACK UP. HER BLOOD GLUCOSE WAS 130 MG/DL. THE CUSTOMER STATED THE INSULIN PUMP HAD NOT BEEN BUMPED, DROPPED, OR EXPOSED TO MOISTURE AND THERE WAS NO APPARENT DAMAGE. THE CUSTOMER INSERTED A NEW BATTERY AND THE DISPLAY DID NOT RETURN. AFTER THE CUSTOMER WAS ADVISED TO REMOVE THE BATTERY FOR 10 MINUTES AND CLEAN THE BATTERY CAPT CONTACTS, ALLOW TO DRY, AND INSERT A NEW BATTERY, THE CUSTOMER STATED THE DISPLAY DID NOT RETURN. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE AND REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721752 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR