BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183023 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39978
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    August 23, 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
    CA
    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 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 INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THE INSULIN PUMP ALARMED FOR MOTOR ERROR AND NO DELIVERY. THE CUSTOMER ALSO STATED THAT HE HAD BEEN HAVING TROUBLE WITH HIGH BLOOD GLUCOSE. BLOOD GLUCOSE READINGS HAVE BEEN AROUND 300 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE ALARM HISTORY ON THE INSULIN PUMP SHOWED MOTOR ERROR AND MULTIPLE NO DELIVERY ALARMS. ADVISED CUSTOMER TO CALL WHEN THE NO DELIVERY ALARM OCCURS SO TROUBLESHOOTING CAN BE PERFORMED. CUSTOMER STATED THAT HE HAD A BACK-UP PLAN AND WILL CONTINUE TO USE THE INSULIN PUMP DESPITE THE MOTOR ERROR ALARM AND MULTIPLE NO DELIVERY ALARMS. ADVISED THAT THE INSULIN PUMP SHOULD BE RETURNED FOR ANALYSIS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661593 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR