BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4242767 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50263
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    September 22, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    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. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    INSULIN PUMP WAS RECEIVED WITH CRACKED CASE ON DISPLAY WINDOW CORNER, MINOR SCRATCHES ON LCD WINDOW, CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER HAD A PHYSICAL DAMAGE ON INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN MG/DL. THE CUSTOMER STATED THAT INSULIN PUMP HAD A LARGE CRACK WRAPPING AROUND TOP RIGHT CORNER. THE CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726087 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR