BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4221644 · Received November 3, 2014

    Report

    Report Number
    2032227-2014-46589
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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

    INSULIN PUMP RECEIVED WITH INTERMITTENT RESPONSE, DUE TO CORRODED KEYPAD TRACES. NO UNEXPECTED ALARMS NOTED DURING TESTING. INSULIN PUMP PASSED SELF TEST. INSULIN PUMP RECEIVED WITH CRACKED CASE ON THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON LCD WINDOW, CRACKED BELT CLIP SLOT, STAINED END CAP STICKER AND CRACKED BATTERY TUBE THREADS. INSULIN PUMP RECEIVED WITH MOISTURE DAMAGE NOTED ON THE ELECTRONICS AND VIBRATOR MOTOR.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP WAS RECENTLY EXPOSED TO WATER AND MOISTURE WAS NOW VISIBLE IN THE DISPLAY. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP RETURNED A BUTTON ERROR ALARM ALONG WITH TWO ADDITIONAL ERROR ALARMS. BLOOD GLUCOSE LEVEL WAS 120 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702317 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 24 YR