BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4052492 · Received September 2, 2014

    Report

    Report Number
    2032227-2014-15397
    Event Type
    Malfunction
    Date Received
    September 2, 2014
    Date of Event
    August 3, 2014
    Report Date
    August 3, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTONS DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. NO TRACES OF MOISTURE WERE NOTED AT THE ELECTRONIC OR MOTOR ASSEMBLIES PER VISUAL INSPECTION. THE DEVICE WAS RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, RESERVOIR TUBE AND BATTERY TUBE THREADS, MINOR SCRATCHED DISPLAY WINDOW, MISSING END CAP STICKER, AND BROKEN RESERVOIR TUBE LIP.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. CUSTOMER STATED THAT THE INSULIN PUMP MAY HAVE BEEN EXPOSED TO SWEAT. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 136 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533842 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR