BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4160416 · Received September 20, 2014

    Report

    Report Number
    2032227-2014-26226
    Event Type
    Malfunction
    Date Received
    September 20, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH BLANK DISPLAY DUE TO MOISTURE DAMAGE ON ELECTRONICS NOTED. MOTOR ERROR ALARM WAS NOT VERIFIED DUE TO BLACK SCREEN. BLANK SCREEN WAS CAUSED WHEN THE BUTTONS WERE PRESSED. THE MOTOR PASSED THE MOTOR TEST. THE DEVICE WAS RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, BROKEN BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP, AND CRACKED RESERVOIR TUBE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A MOTOR ERROR ALARM FOLLOWED BY A BLANK SCREEN, THEN WHEN THE PUMP TURNED BACK ON ANOTHER MOTOR ALARM OCCURED. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME 218 MG/DL. ADVISED INSULIN PUMP WOULD BE REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585753 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR