BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4862410 · Received June 23, 2015

    Report

    Report Number
    2032227-2015-19910
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    June 4, 2015
    Report Date
    June 4, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED FAILED BATTERY TEST DUE TO FAULTY BATTERY TUBE. THE INSULIN PUMP FUNCTIONED PROPERLY AFTER UNPLUGGING AND PLUGGING THE BATTERY TUBE CONNECTOR INTO INTERFACE BOARD. THE INSULIN PUMP HAD MINOR SCRATCHES ON LCD WINDOW, CRACKED LCD WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED BELT CLIP SLOT AND CRACKED RESERVOIR TUBE LIP.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THE INSULIN PUMP ALARM FAILED BATTERY TEST. CUSTOMER'S BLOOD GLUCOSE WAS 120 MG/DL. THE CUSTOMER WAS ADVISED TO INSERT NEW AAA ALKALINE BATTERY. CUSTOMER RECEIVED FAILED BATTERY TEST. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A ALKALINE UP PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406118 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR