BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183065 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40033
    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
    KY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS ABLE TO DOWNLOAD TO THE CARELINK SOFTWARE WITHOUT ANY ERRORS. THE INSULIN PUMP PASSED THE SELF TEST. THERE WAS NO SIGNAL TO LOW ALARM DURING TESTING. HOWEVER, ERROR ALARM THAT WAS FOUND IN THE ALARM HISTORY FILE WAS DUE TO CORRUPTED HISTORY FILE. THE INSULIN PUMP PASSED THE UNEXPECTED RESTART ERROR TEST. THERE WAS NO UNEXPECTED RESTART ALARM NOTED. THE UNIT HAD MINOR SCRATCHES TO LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW, CRACKED RESERVOIR TUBE LIP, BELT CLIP SLOT, BATTERY TUBE THREADS AND STAINED END CAP STICKER.

    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).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP RETURNED MULTIPLE ERROR ALARMS. THE PRESENCE OF THESE ERROR ALARMS IN THE INSULIN PUMP'S ALARM HISTORY WAS PREVENTING SOFTWARE UPLOAD. BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660473 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR