BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3984502 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-90349
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 6, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP PASSED BASIC OCCLUSION TEST AND DISPLACEMENT TEST. NO MOTOR ERROR ALARMS WERE NOTED. INSULIN PUMP WAS UNABLE TO PRIME UNIT DURING PRIME TEST DUE TO FAULTY FORCE SENSOR. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. INSULIN PUMP RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS, SCRATCHED DISPLAY WINDOW AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR AND A MOTOR ERROR DURING BOLUS DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER DOES NOT USE THE SENSOR FEATURE. THEY WERE ABLE TO REWIND THE DEVICE. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460257 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 35 YR