BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4150099 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-34843
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    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

    INSULIN PUMP WAS MONITORED FOR 48 HOURS FOR BASAL RATE, PASSED SELF TEST. NO ALARMS NOTED. INSULIN PUMP PASSED DISPLACEMENT TEST. UNABLE TO COMPLETE DOWNLOAD DUE TO MULTIPLE ALARMS NOTED IN THE ALARM HISTORY SCREEN. INSULIN PUMP ALARMED DISPLAY HISTORY FAILED ON STARTUP NOTED, DUE TO CORRUPTED HISTORY FILES. INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS TRYING TO UPLOAD THE INSULIN PUMP TO CARELINK PRO AND IT KEPT COMING BACK AS TEST FAILED. CUSTOMER'S BLOOD GLUCOSE WAS 109 MG/DL. CUSTOMER STATED THAT THERE WAS NEW SOFTWARE RELEASE DETECTED ALARM IN THE HISTORY. ADVISED CUSTOMER THE INSULIN PUMP WOULD BE REPLACED. ADVISED TO DISCONTINUE USING THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROVIDER. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628189 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR