BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4780984 · Received May 19, 2015

    Report

    Report Number
    2032227-2015-16092
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 28, 2015
    Report Date
    April 28, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED BUTTON ERROR AFTER BOOT UP AND INTERMITTENT BUTTON RESPONSE ON THE ESCAPE BUTTON DUE TO MOISTURE DAMAGE ON KEYPAD TRACES NOTED. THE INSULIN PUMP HAS BROKEN BELT CLIP SLOT NOTED, CRACKED LCD WINDOW, CRACKED CASE AT LCD WINDOW CORNERS, BROKEN RESERVOIR TUBE LIP, SCRATCHES ON RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS AND STAINED ENDCAP STICKER. NO BELT CLIP RECEIVED WITH THE RETURN OF THE INSULIN PUMP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE, THE INSULIN PUMP ALARMED BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE WAS 87 MG/DL. CUSTOMER DOES NOT RECALL ANY SIGNIFICANT EVENTS WHICH MAY HAVE LED TO THE ALARM. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE, REVERT TO BACK UP PLAN, AND DEVICE NEEDED TO BE REPLACED. CUSTOMER AGREED TO RETURN THE DEVICE FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327020 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR