BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4221419 · Received November 3, 2014

    Report

    Report Number
    2032227-2014-46697
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP WAS RECEIVED WITH NO ESC BUTTON RESPONSE DUE TO FLATTENED BUTTON DOME SWITCH. NO UNEXPECTED AUDIO/BEEP ANOMALY NOTED. UNABLE TO VERIFY FOR RESET ALARM AND DISPLAY HISTORY FAILED START UP ALARM DUE TO NO ESC BUTTON RESPONSE. INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS.

    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 THE INSULIN PUMP ALARMED DISPLAYABLE HISTORY CRC CHECK FAILED ON STARTUP. CUSTOMER'S BLOOD GLUCOSE WAS 223 MG/DL. ALARM AND POSSIBLE CAUSES WERE EXPLAINED TO CUSTOMER'S MOTHER. A TEMP BASAL WAS NOT PROGRAMMED BEFORE THE ALARM. CUSTOMER WAS SITTING DOWN WHEN ALARM OCCURRED. THE DEVICE STILL HAD THE BASAL AND BOLUS WIZARD SETTING SET ON THE DEVICE. THE RESET ALARM DID OCCUR WITHIN THREE MINUTES OF UNSUCCESSFUL "WRITE SETTINGS" ATTEMPT USING PARADIGM PAL SOFTWARE. CUSTOMER'S MOTHER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701629 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR