BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4201197 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-42811
    Event Type
    Malfunction
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH AN INTERMITTENT BUTTONS, DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. NO TRACES OF MOISTURE WERE NOTED AT ELECTRONIC OR MOTOR ASSEMBLIES PER VISUAL INSPECTION. INSULIN PUMP HAD A CRACKED CASE AT DISPLAY WINDOW CORNERS, DISPLAY WINDOW AND BATTERY TUBE THREADS AND MINOR SCRATCHES ON LCD WINDOW.

    Additional Manufacturer Narrative · 1

    (B)(4).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 WAS RECEIVING A BUTTON ERROR ALARM ON HIS INSULIN PUMP. HIS BLOOD GLUCOSE WAS 61MG/DL AT THE TIME OF REPORTING. THE CUSTOMER WAS ADVISED TO REVERT TO HIS BACKUP PLAN. THE PUMP IS BEING RETURNED. NO ADDITIONAL INFORMATION TO RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681657 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR