BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4081440 · Received September 11, 2014

    Report

    Report Number
    2032227-2014-21278
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 12, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH CRACKED CASE ON THE DISPLAY WINDOW CORNERS, MINOR SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE LIP, CRACKED BELT CLIP SLOT, AND CRACKED BATTERY TUBE THREADS. INTERMITTENT BUTTON RESPONSE NOTED DUE TO CORRODED KEYPAD TRACES. NO MOISTURE DAMAGE ON THE MOTOR OR ELECTRONIC ASSEMBLY NOTED DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 160 MG/DL. THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS EXPOSED TO WATER. THE CUSTOMER REPORTED THAT THERE WAS FLUID INSIDE THE DISPLAY OF THE INSULIN PUMP. THE CUSTOMER ALSO REPORTED A SMALL CRACK ON THE DISPLAY OF THE INSULIN PUMP. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK-UP PLAN PER THE HEALTH CARE PROVIDER'S INSTRUCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561510 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR