BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3183243 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-94912
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 1, 2013
    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

    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.

    Additional Manufacturer Narrative · 1

    MOTOR ERROR ALARMED DURING REWIND DUE TO OUT OF PHASE MOTOR ENCODER SIGNAL. UNABLE TO PERFORM DISPLACEMENT TEST DUE TO MOTOR ERROR ALARMS. NO ALARMS NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED AN ERROR. THE BLOOD GLUCOSE READING WAS 172MG/DL. THE DISPLACEMENT TEST WAS PERFORMED AND THE DEVICE FAILED THE TEST. ADVISED THE CALLER THAT THE INSULIN PUMP 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
    283956 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 64 YR