BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4200470 · Received October 24, 2014

    Report

    Report Number
    2032227-2014-42481
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT POWER UP PROPERLY AFTER BATTERY INSTALLATION. UNIT RECEIVED WITH OPERATING CURRENTS WITHIN SPEC. NO UNEXPECTED LOW BATTERY, WEAK BATTERY OR FAILED BATTERY TEST ALARMS NOTED. BATTERY ICON INDICATOR DISPLAYED PROPERLY BATTERY CHARGE. UNIT PASSED BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. NO UNEXPECTED NO DELIVERY ALARMS WERE NOTED. UNIT RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS. UNIT RECEIVED WITH SEVERELY SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 145 MG/DL. IT WAS REPORTED THAT THE BATTERIES ON THE INSULIN PUMP OF THE CUSTOMER DID NOT LAST LONG. THE CUSTOMER ALSO REPORTED RECEIVING A LOW BATTERY ALARM AND A FAILED BATTERY TEST ALARM FROM THE INSULIN PUMP IN VARIOUS INSTANCES. TROUBLESHOOTING WAS DONE. A NEW BATTERY CAP WAS SENT TO THE CUSTOMER. THE CUSTOMER RECEIVED THE NEW BATTERY CAP FOR THE INSULIN PUMP AND INSTALLED NEW BATTERIES ON THE INSULIN PUMP. THE CUSTOMER REPORTED RECEIVING A FAILED BATTERY TEST ALARM FROM THE INSULIN PUMP. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK-UP PLAN PER THE HEALTH CARE PROVIDER'S INSTRUCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678976 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR