BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4181400 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39656
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, COMPROMISED FORCE SENSOR, NO DELIVERY AND MOTOR TESTS. THERE WAS NO MOTOR ERROR ALARM NOTED. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE INSULIN PUMP WAS RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW, STAINED END CAP STICKER AND CRACKED BATTERY TUBE THREADS.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A MOTOR ERROR ALARM ON HER INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 160 MG/DL. CUSTOMER'S SPOUSE SAID THAT THEY WERE CHANGING THE SITE AND RESERVOIR WHEN THE MOTOR ERROR OCCURRED. CUSTOMER WAS ASSISTED WITH CLEARING THE ALARM. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE PUMP. CUSTOMER WAS ABLE TO COMPLETE THE REWIND SEQUENCE, BUT THEN IT WENT BACK TO MOTOR ERROR. INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER'S SPOUSE WAS UNABLE TO RETRIEVE THE SETTINGS FROM THE PUMP BECAUSE IT KEEPS BEEPING FOR THE MOTOR ERROR. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660956 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR