BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3982355 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-90099
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH MOTOR ERROR ALARM DURING REWIND DUE TO MOTOR ENCODER SIGNAL OUT OF PHASE. UNABLE TO PERFORM NO DELIVERY TEST OR DISPLACEMENT TEST DUE TO MOTOR ERROR ALARM. THE INSULIN PUMP HAD MINOR SCRATCHED LCD WINDOW, CRACKED DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, CRACKED BELT CLIP SLOT AT THE BATTERY TUBE THREADS AREA AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ISSUES WITH THE INSULIN PUMP. THE BLOOD GLUCOSE READING IS 102 MG/DL. CUSTOMER STATES THAT THE INSULIN DIDN'T EXIT AND THE PUMP ALARMED NO DELIVERY. CUSTOMER WENT THROUGH THE DISPLACEMENT TEST PROCESS AND THE TEST FAILED. THE INSULIN PUMP DID NOT ALARM LOW RESERVOIR. NOTHING FURTHER REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458384 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR