BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4771241 · Received May 14, 2015

    Report

    Report Number
    3004209178-2015-56177
    Event Type
    Malfunction
    Date Received
    May 14, 2015
    Date of Event
    April 23, 2015
    Report Date
    April 23, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. HOWEVER, THE PUMP HAD MINOR SCRATCHES ON THE 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 REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED OFF NO POWER, LOST SENSOR, MOTOR ERROR, AND RADIO FREQUENCY PROGRAMMABLE INTEGRATED CIRCUIT FAILED SELF TEST. THE CUSTOMER'S BLOOD GLUCOSE WAS 127 MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD BEEN DROPPED, BUT NO DAMAGE TO THE DEVICE WAS OBSERVED. HE STATED THAT, UPON INSERTING A NEW BATTERY, THE BATTERY INDICATOR SHOWED ONLY 2 BARS OF POWER. THE CUSTOMER WAS NOT USING THE RECOMMENDED BRAND OF BATTERIES AND USED BATTERIES THAT WERE REFRIGERATED; HE WAS ADVISED AGAINST DOING SO. HE AGREED TO USE THE RECOMMENDED BRAND NEXT TIME. HE STATED THAT HE DID NOT RECEIVE A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALERT. HE DID NOT HAVE A NEW BATTERY WITH WHICH TO TEST. THE CUSTOMER WAS ADVISED TO REPLACE THE INSULIN PUMP AND AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317110 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 55 YR