BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4142038 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33645
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: NO A17 ALARM, A21 ALARM, RESET ALARM OR CHECK SETTING ALARM NOTED. UNIT PASSED THE SELF TEST AND A21 ERROR TEST. PUMP RECEIVED WITH A47 ALARM IN THE HISTORY FILE. A47 ALARM DUE TO CORRUPTED HISTORY FILE. ALSO RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD AN UNEXPECTED RESTART ON THE INSULIN PUMP. CUSTOMER WAS ADVISED HOW THE RESET ALARM WOULD OCCUR IN USER SETTINGS. CUSTOMER STATED THAT THE PUMP WAS IN HER PANTS AND WAS NOT PUSHING AGAINST ANYTHING ENOUGH FOR THE BUTTONS TO PRESS. CUSTOMER RAN SELTEST AND PUMP PASSED. CUSTOMER ORIGINALLY CALLED BECAUSE OF A BATTERY CAP THAT COULDN'T COME OFF, BUT SHE WAS ABLE TO GET IT OFF. CUSTOMER WAS WEARING THE PUMP AND WHEN SHE WENT TO WORK, SHE SAW THE RESET ALARM AND HER SETTINGS WERE CLEARED. CUSTOMER IS NO LONGER WEARING THE PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 177 MG/DL. PUMP WILL NEED TO BE REPLACED. CUSTOMER CONFIRMED THAT THE PUMP WAS STORED WITHOUT A BATTERY FOR AN EXTENDED PERIOD OF TIME.CUSTOMER HAD MULTIPLE ALARMS IN THE ALARM HISTORY. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621592 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR