BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4221758 · Received November 3, 2014

    Report

    Report Number
    2032227-2014-46709
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS, A BROKEN BELT CLIP SLOT, AND A 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WENT INTO A HOT TUB FOR 3-5 MINUTES WHILE WEARING THE INSULIN PUMP AND SHE SAID THAT HER PUMP WAS CURRENTLY FUNCTIONING PROPERLY. CUSTOMER DOES NOT SEE ANY CONDENSATION OR LIQUID UNDERNEATH THE LCD SCREEN. CUSTOMER WANTS TO KNOW WHAT TO DO SINCE THERE WAS SOME MOISTURE EXPOSURE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 119 MG/DL. CUSTOMER REPORTED THAT THE FLUID/MOISTURE EXPOSURE TO THE PUMP IS WATER. CUSTOMER STATED THAT ALL OF THE BUTTONS ARE WORKING FINE AND THE LIGHT GOES ON. PUMP APPEARS TO BE FUNCTIONING AS DESIGNED. CUSTOMER STATED THAT IN THE WORSE CASE SCENARIO, SHE WILL HAVE TO VISIT A HOSPITAL. CUSTOMER SWITCHED DOCTORS AND HAS A BACKUP PLAN. CUSTOMER HAS APPEDRIA AND LANTUS MANUAL INJECTIONS. INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL'S INSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702684 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP A8723NAPJ

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR