BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4031739 · Received August 22, 2014

    Report

    Report Number
    3004209178-2014-97189
    Event Type
    Malfunction
    Date Received
    August 22, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER HAS BEEN HAVING ISSUES WITH THE INSULIN PUMP. CUSTOMER STATED THE DEVICE WAS BEEPING AND VIBRATING LAST NIGHT. THE DEVICE WILL DO BLOCK ON AND OFF, TURN THE SENSOR ON WHEN THE SENSOR WAS NOT USED WITH THE DEVICE. THE DEVICE HAS AN OPEN CIRCLE BY RESERVOIR ICON AND WAS UNABLE TO CLEAR IT. ALARM HISTORY SHOWED AN AUTO OFF ALARM. ALARM WAS EXPLAINED TO CUSTOMER. CUSTOMER HAD SENSOR FEATURE SET ALARM HIGH, CHANGED TO OFF. CUSTOMER STATED THE DEVICE ALERTED DURING THE DAY, UNCLEAR WHAT ALERTS IT WAS. CUSTOMER'S BLOOD GLUCOSE WAS 9MMOL/L. SELF TEST WAS CONDUCTED ON THE DEVICE AND IT PASSED. THE DEVICE MIGHT HAVE A STUCK BUTTON AND MIGHT BE CAUSE OF WHY THE DEVICE GOES IN DIFFERENT MENUS. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509745 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR