BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3982322 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06173
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 6, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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

    INSULIN PUMP HAD A BLANK DISPLAY DUE TO MOISTURE DAMAGE ON ELECTRONIC ASSEMBLY. A CORRODED MOTOR HOME SWITCH ALSO NOTED. UNABLE TO CONFIRM BEEPING WITH LINES ON THE DISPLAY DUE TO BLANK DISPLAY. INSULIN PUMP HAD A CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON DISPLAY WINDOW AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE THINKS THE INSULIN PUMP HAS WATER DAMAGE. THE DEVICE STARTED BEEPING WITH LINE AND NUMBER ON THE SCREEN. CUSTOMER TOOK OUT THE BATTERY FOR AWHILE THEN REPLACED IT AND THE DISPLAY STAYED BLANK. CUSTOMER'S BLOOD GLUCOSE WAS 61 MG/DL. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED THE DEVICE WENT INTO THE POOL. FLUID IS LOCATED UNDER THE LCD DISPLAY. CUSTOMER STATED THE DEVICE WAS NOT DROPPED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457100 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723PNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR