BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3791253 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-84238
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP ALARMED MOTOR ERROR DURING REWIND DUE TO A MOTOR ENCODER SIGNAL OUT OF PHASE. UNABLE TO PERFORM THE DISPLACEMENT TEST, TEST THE LOW RESERVOIR ALARM OR CHECK FOR THE UNITS REMAINING IN STATUS SCREEN ANOMALY DUE TO THE MOTOR ERROR ALARM. CRACKS TO THE CASE, BATTERY TUBE THREADS, RESERVOIR TUBE, RESERVOIR TUBE WINDOW AND RESERVOIR TUBE LIP NOTED.

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING AN MRI AND THE INSULIN PUMP ALARMED MOTOR ERROR THE NIGHT BEFORE. THE BLOOD GLUCOSE READING WAS 114MG/DL. TROUBLESHOOTING WAS PERFORMED, AND NO DAMAGE TO THE DRIVE SUPPORT CAP NOTED. ASSISTED THE CALLER TO RUN THE DISPLACEMENT TEST AND THE TEST FAILED. THE DEVICE WAS SHOWING ALMOST 100% FULL, BUT THE CUSTOMER GOT A LOW RESERVOIR ALARM ALSO. ADVISED THE CALLER THAT THE DEVICE WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268694 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR