BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103358 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25212
    Event Type
    Malfunction
    Date Received
    September 19, 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
    PA
    Reporter Occupation
    PATIENT

    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

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP PASSED THE DISPLACEMENT TEST AND THE ERROR ALARM TEST. NO ERROR ALARM NOTED. THE DEVICE WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. THE UNIT WAS RECEIVED WITH MOISTURE DAMAGE AT THE MOTOR AND THE ELECTRONIC ASSEMBLIES, MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP AND SCRATCHED CASE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP HAD RECENTLY BEEN EXPOSED TO MOISTURE. CUSTOMER REPORTED REMOVING THE BATTERY, REPLACING IT, THEN RECEIVING AN ERROR ALARM. CUSTOMER STATED THAT SOME BUTTONS ON THE KEYPAD WERE NO LONGER RESPONSIVE. BLOOD GLUCOSE LEVEL WAS 45 MG/DL AT THE TIME OF THE CALL. CUSTOMER REPORTED TREATING THE LOW BLOOD GLUCOSE LEVEL WITH A BOWL OF CEREAL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585044 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR