BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4192931 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41349
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    August 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER

    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

    THE INSULIN PUMP WAS MONITORED FOR SEVERAL DAYS AND NO BLANK DISPLAY NOTED. THE INSULIN PUMP WAS RECEIVED WITH NORMAL OPERATING CURRENTS. OFF NO POWER ALARM FUNCTIONS PROPERLY. NO DAMAGE WAS FOUND ON THE LCD ISOLATION TAPE NOTED. HOWEVER, THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED LCD WINDOW, CRACKED BELT CLIP SLOT, CRACKED RESERVOIR TUBE LIP, SCRATCHED RESERVOIR TUBE WINDOW AND STAINED END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP'S POWER WAS SHUTTING OFF EVEN WITH FULL BATTERY. THE CUSTOMER WOKE UP WITH HIGH BLOOD GLUCOSE LEVELS AND KETONES BECAUSE THE INSULIN PUMP POWERED OFF IN THE MIDDLE OF THE NIGHT. ACTUAL BLOOD GLUCOSE LEVELS WERE NOT REPORTED. PHYSICAL DAMAGE WAS ALSO REPORTED: A CRACK BETWEEN BATTERY COMPARTMENT AND RESERVOIR COMPARTMENT. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO BACK-UP PLAN. THE PRODUCT WAS RETURNED. NOTHING FURTHER TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674261 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 18 YR