BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183172 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40069
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 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. 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

    A CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW, AND A SCRATCHED CASE WERE NOTED DURING THE VISUAL INSPECTION. THE INSULIN PUMP WAS MONITORED AND ALL OPERATING CURRENTS TESTED WITHIN SPECIFICATION. NO FAILED BATTERY TEST ALARM WAS NOTED.

    Description of Event or Problem · 1

    NO BLOOD GLUCOSE LEVELS WERE PROVIDED. THE CUSTOMER REPORTED A FAILED BATTERY TEST ALARM FROM THE INSULIN PUMP. THE CUSTOMER REPORTED USING A USED BUT PROPERLY FUNCTIONING BATTERY FOR THE INSULIN PUMP. TROUBLESHOOTING WAS DONE. THE CUSTOMER WAS ADVISED TO USE NEW AAA ALKALINE BATTERIES FOR THE INSULIN PUMP. A NEW BATTERY WAS INSTALLED ON THE INSULIN PUMP. THE CUSTOMER RECEIVED ANOTHER FAILED BATTERY TEST 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
    660772 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR