BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4841259 · Received June 12, 2015

    Report

    Report Number
    3004209178-2015-64954
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 25, 2015
    Report Date
    May 25, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    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.

    Additional Manufacturer Narrative · 1

    NO UNEXPECTED BUTTON ERROR ALARMS NOTED. THE INSULIN PUMP HAD AN INTERMITTENT BUTTON RESPONSE ON THE UP ARROW BUTTON DUE TO CORRODED KEYPAD TRACES NOTED. THE INSULIN PUMP HAD A CRACKED LCD WINDOW, CRACKED CASE AT LCD WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, SCRATCHES ON RESERVOIR TUBE WINDOW AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE ALARM. BLOOD GLUCOSE VALUE WAS 130 MG/DL. CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO A BACK A PLAN. CUSTOMER WAS ADVISED THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386655 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR