BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3974190 · Received August 1, 2014

    Report

    Report Number
    2032227-2014-05223
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE CUSTOMER WAS RECEIVING A MOTOR ERROR ALARM ON HER INSULIN PUMP AS SHE WAS TRYING TO PRIME. THE CUSTOMER'S BLOOD GLUCOSE WAS 126 MG/DL AND DOES NOT RECALL ANY SPECIFIC EVENTS THAT COULD POSSIBLY HAVE LED TO THE MOTOR ALARM. THE CUSTOMER WAS ADVISED THAT THE PUMP NEEDED TO BE REPLACED AND THAT THE CUSTOMER WAS TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. NO FURTHER INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450116 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR