BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4153692 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-24899
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP FAILED THE DISPLACEMENT TEST AND ALARMED FOR A MOTOR ERROR DURING THE REWIND DUE TO A MOTOR ENCODER SIGNAL OUT OF PHASE. NO COSMETIC DAMAGE WAS 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. 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 RECEIVED A MOTOR ERROR ALARM ON THE INSULIN PUMP DURING A BASAL RATE INSULIN DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE WAS 78 MG/DL. DURING TROUBLESHOOTING, IT WAS FOUND THAT THE INSULIN PUMP WAS WITH THE PATIENT DURING MAGNETIC RESONANCE IMAGING. THE CUSTOMER DOES NOT USE THE SENSOR FEATURE ON THE INSULIN PUMP. SHE WAS UNABLE TO REWIND THE INSULIN PUMP AND WAS ADVISED TO DISCONTINUE USE AND REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632009 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR