BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972159 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05131
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 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
    WA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO BLANK DISPLAY NOTED. THE INSULIN PUMP HAD NO BUTTON RESPONSE DUE TO MOISTURE DAMAGE ON KEYPAD TRACES. UNABLE TO TEST THE OPERATING CURRENTS DUE TO NO BUTTON RESPONSE. THE INSULIN PUMP HAD A CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP AND MINOR SCRATCHED DISPLAY WINDOW. THE INSULIN PUMP HAD MOISTURE DAMAGE ON ELECTRONIC ASSEMBLY AND ON MOTOR.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP WAS EXPOSED TO FLUID AND NO LONGER WAS WORKING. CUSTOMER STATED THAT SHE GOT PUSHED INTO THE POOL. THE BLOOD GLUCOSE READING WAS 472 MG/DL. SHE STATED THAT NO MOISTURE WAS VISIBLE IN THE INSULIN PUMP. SHE STATED THAT THE DISPLAY WENT BLANK IMMEDIATELY AFTER THE MOISTURE EXPOSURE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448008 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR