BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4840903 · Received June 12, 2015

    Report

    Report Number
    3004209178-2015-64833
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS MONITORED AND NO BLANK DISPLAY ANOMALIES WERE NOTED. NO DAMAGE ON THE LCD ISOLATION TAPE NOTED. THE INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. THE OPERATING CURRENTS ARE WITHIN SPECIFICATION. THE INSULIN PUMP HAS RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, BATTERY TUBE THREADS AND MINOR SCRATCHED DISPLAY WINDOW.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER'S SPOUSE REPORTED VIA PHONE CALL THAT THE CUSTOMER HAD A BLANK DISPLAY ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE WAS 300 MG/DL. CUSTOMER PUT IN NEW BATTERIES BUT THE SCREEN WAS BLANK. CUSTOMER HAS ALREADY TRIED 2 BATTERIES PRIOR TO CALLING. CUSTOMER STATED THAT THE DISPLAY DID NOT RETURN. CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ALSO ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385510 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR