BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4231281 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48465
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    NO BUTTON ERROR ALARM WAS NOTED. THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW, A MISSING END CAP STICKER AND CRACKED BATTERY TUBE THREADS. ALL OPERATING CURRENTS WERE WITHIN SPECIFICATION AND THE OFF NO POWER ALARM FUNCTIONED PROPERLY. NO BLANK DISPLAY OR DAMAGE TO THE ISOLATION TAPE WAS NOTED.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTED A BUTTON ERROR ON CUSTOMER'S INSULIN PUMP. CUSTOMER TRIED CLEARING THE ALARM SEVERAL TIMES BUT COULD NOT, AND THEN THE DEVICE WENT BLANK. REPLACING THE BATTERY DID NOT RESOLVE THE ISSUE. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THERE WERE NO SIGNIFICANT EVENTS LEADING TO THE ALARM. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715968 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR