BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3984463 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-90293
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 6, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    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 MONITORED FOR 24 HOURS WITH MULTIPLE BASAL RATES. NO ALARM WAS NOTED DURING TESTING BUT THE ALARM WAS FOUND IN THE INSULIN PUMP HISTORY AND HAD ALARMED DUE TO CORRUPTED HISTORY. THE INSULIN PUMP PASSED THE SELF TEST. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT DISPLAY WINDOW CORNERS, A CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE NEAR RESERVOIR TUBE WINDOW AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MULTIPLE ERROR ALARMS, AFTER THE CUSTOMER INSERTED NEW BATTERIES, DURING NORMAL USE AND DURING REWIND/PRIME SEQUENCE. TROUBLESHOOTING WAS UNSUCCESSFUL BECAUSE DURING THE PROCESS THE INSULIN PUMP STARTED ALARMING THE SAME ERRORS. THE CUSTOMER'S BLOOD GLUCOSE WAS 136 MG/DL. THE CUSTOMER STATED THAT THERE WAS A CRACK ON THE DEVICE. THE DISCONTINUATION OF THE INSULIN PUMP WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460198 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR