BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972390 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05144
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 29, 2014
    Report Date
    July 1, 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

    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

    A CRACKED RESERVOIR TUBE LIP AND MINOR SCRATCHES ON THE DISPLAY WINDOW WERE NOTED DURING THE VISUAL INSPECTION. THE INSULIN PUMP HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO NUMBER RAMPING ANOMALY WAS NOTED ON THE DISPLAY. MOISTURE DAMAGE WAS NOTED ON THE ELECTRONIC ASSEMBLY. NO MOISTURE DAMAGE WAS NOTED ON THE MOTOR ASSEMBLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP WAS EXPOSED TO FLUID. SHE STATED THAT SHE WENT SWIMMING WITH THE INSULIN PUMP AND THAT IT WAS SUPPOSED TO BE WATERPROOF. AFTER THIS, THE BUTTONS BECAME UNRESPONSIVE AND THE NUMBERS BEGAN MOVING WITHOUT INPUT. SHE REPORTED THAT THERE WAS FLUID UNDER THE DISPLAY SCREEN. SHE STATED THAT THE INSULIN PUMP HAD NOT BEEN DROPPED BUT THE BATTERY CAP HAD BEEN SCRATCHED UP. THE BLOOD GLUCOSE READING WAS 474 MG/DL. CUSTOMER TREATED WITH A MANUAL INJECTION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446732 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR