BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4993659 · Received August 11, 2015

    Report

    Report Number
    2032227-2015-27594
    Event Type
    Injury
    Date Received
    August 11, 2015
    Date of Event
    July 19, 2015
    Report Date
    July 19, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT POWER UP PROPERLY AFTER BATTERY INSTALLATION. UNIT RECEIVED WITH OPERATING CURRENTS WITHIN SPEC. NO LOW BATTERY ALARMS OR FAILED BATTERY TEST NOTED. UNIT RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. NO DISPLAY RAMPING ON ITS OWN ANOMALY NOTED. UNIT RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW. UNIT RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS AND BATTERY TUBE THREADS. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA PHONE CALL, THAT THE CUSTOMER RECEIVED A BUTTON ERROR ALARM. IT WAS ALSO REPORTED THAT THE CUSTOMER PREVIOUSLY WENT INTO DIABETIC KETOACIDOSIS. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME 329 MG/DL. TROUBLESHOOTING OCCURRED. ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP, AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527544 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other