BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4201346 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-42346
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    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

    THE PATIENT'S REPORTED THAT THE INSULIN PUMP HAD A MOTOR ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 473 MG/DL. THE CUSTOMER'S EXPLAINED THAT IN THE MIDDLE OF GIVING HERSELF A BOLUS THE INSULIN PUMP ALARMED MOTOR ERROR. THE TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ASSISTED ON HOW TO CLEAR THE ALARM, DISCONNECT FROM THE INSULIN PUMP. SHE WAS ALSO ADVISED TO RETRIEVE THEIR INSULIN PUMP SETTING AND RETURNED WITH THE BATTERY AND ZERO OUT THE BASAL RATES. THE PATIENT'S WAS ADVISED TO DISCONTINUED THE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN. NO FURTHER INFORMATION WAS ADDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683844 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR