BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3984380 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-90525
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 6, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD NO MOISTURE DAMAGE FOUND ON THE ELECTRONICS, MOTOR, VIBRATOR, AND BATTERY TUBE ASSEMBLY DURING VISUAL INSPECTION. NO UNEXPECTED NUMBERS RAMPING DURING TEST. INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORROSION ON KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED DURING TESTING. INSULIN PUMP HAD A CRACKED CASE ON THE LCD DISPLAY WINDOW CORNERS, MINOR SCRATCHES ON LCD DISPLAY WINDOW, CRACKS ON THE BATTERY TUBE THREADS, CRACKS ON THE RESERVOIR TUBE LIP AND SCRATCHES ON THE RESERVOIR TUBE WINDOW.

    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

    CUSTOMER REPORTED A BUTTON ERROR ALARM. CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO FLUID AND NUMBERS STARTED RAMPING WHEN HE GAVE HIMSELF A BOLUS. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 303 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461452 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR