BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4193636 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41332
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH MOTOR ERROR ALARM DURING REWIND DUE TO MOTOR ENCODER SIGNAL OUT OF PHASE. NO ERROR ALARM NOTED DURING TESTING. THE INSULIN PUMP WAS UNABLE TO PERFORM DISPLACEMENT TEST DUE TO MOTOR ERROR ALARM. THE INSULIN PUMP HAD A CRACKED CASE AT DISPLAY WINDOW CORNER AND CRACKED RESERVOIR TUBE LIP.

    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

    IT WAS REPORTED THAT THE CUSTOMER HAD A MOTOR ERROR ALARM ON HIS INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 162 MG/DL. CUSTOMER STATED THAT LAST NIGHT HE WAS GIVING A BOLUS AND THE PUMP ALARMED MOTOR ERROR. CUSTOMER WENT TO REWIND AND RECEIVED A MOTION SENSOR TEST FAILURE ALARM. AFTER ABOUT 5 MINUTES OF REWINDING, HE IS ABLE TO PRIME. AFTER PRIMING, THE CUSTOMER RECEIVED ANOTHER MOTOR ERROR ALARM. CUSTOMER WAS UNABLE TO PERFORM A DISPLACEMENT TEST. CUSTOMER STATED THAT HE WAS UNABLE TO COMPLETE THE REWIND SEQUENCE. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672595 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR