BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4192978 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41644
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP WAS ALARMING BATTERY OUT LIMIT AND HAD A BLANK DISPLAY SCREEN. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED IF THE DEVICE SHOWED PHYSICAL DAMAGE AND CUSTOMER STATED THE DISPLAY SCREEN WAS LIGHTLY SCRATCHED. NEXT, CUSTOMER WAS ASKED TO IDENTIFY THE BRAND OF BATTERIES USED IN THE DEVICE. CUSTOMER STATED GENERIC BRAND AND WAS ADVISED TO USE APPROVED ALKALINE BATTERIES. AFTERWARDS, CUSTOMER WAS ASKED TO INSERT APPROVED BATTERIES INTO DEVICE. CUSTOMER STATED DISPLAY RETURNED AND ADVISED TO MONITOR DEVICE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 200 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672432 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 68 YR