BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4122879 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-28757
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 HAD AN UNRESPONSIVE ACT BUTTON DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM WAS NOTED DURING TESTING. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, A MISSING END CAP STICKER AND A CRACKED RESERVOIR TUBE NEAR THE RESERVOIR TUBE WINDOW. NO MOISTURE DAMAGE WAS FOUND INSIDE OF THE INSULIN PUMP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A BUTTON ERROR ALARM ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 104 MG/DL. CUSTOMER STATED THAT HIS KEYPAD WAS UNRESPONSIVE. IT WAS FOUND THAT THE PUMP WAS EXPOSED TO MOISTURE OVER TIME. CUSTOMER STATED THAT THE PUMP WAS EXPOSED TO SWEAT AND SHOWER WATER. CUSTOMER REPORTED THAT HE WAS WORKING OUTSIDE AND THE CASE OF THE PUMP GOT SOAKED. CUSTOMER STATED THAT THE PUMP WAS ALSO IN THE SHOWER ON THE LEDGE. BUTTON ERROR ALARM WAS PRESENT IN HISTORY AT OR AROUND THE TIME THAT THE PUMP WAS EXPOSED TO MOISTURE. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600729 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR