BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3970044 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88395
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    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

    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS PROGRAMMED AND MONITORED FOR ONE DAY WITH NO ALARM FOR AN UNEXPECTED RESTART, A CORRUPTED HISTORY FILE OR FOR AN EXTERNAL RAM ERROR. THE INSULIN PUMP PASSED THE SELF TEST. THE INSULIN PUMP HAD MULTIPLE ERROR ALARMS IN THE HISTORY SCREEN AND WAS UNABLE TO UPLOAD DATA DUE TO A CORRUPTED HISTORY FILE. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED VARIOUS ERRORS. THE BLOOD GLUCOSE READING WAS 157 MG/DL. THE DIABETES CLINICAL MANAGER VERIFIED THAT THE INSULIN PUMP HAD ALL SETTINGS PROGRAMMED INTO IT PROPERLY. THE ALARMS WERE NOT RECURRING DURING NORMAL DEVICE USE. ADVISED THAT THE INSULIN PUMP HAD EXPERIENCED AN UNEXPECTED RESTART. UPON TROUBLESHOOTING, IT WAS FOUND THAT THE DEVICE WAS ABLE TO REWIND, BOLUS AND PASS THE SELF TEST. EXPLAINED THAT ONE OF THE ALARMS MAY HAVE OCCURRED IF THE INSULIN PUMP HAD BEEN WITHOUT BATTERY FOR AN EXTENDED PERIOD OF TIME AND THAT THIS IS NORMAL DEVICE BEHAVIOR. ADVISED REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446829 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 69 YR