BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4203847 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-43753
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 27, 2014
    Report Date
    September 27, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO UNEXPECTED NUMBER FLASH WAS NOTED. NO UNEXPECTED BUTTON ERROR ALARM WAS NOTED. ALL OF THE BUTTONS FUNCTIONED PROPERLY. NO UNEXPECTED NO DELIVERY ALARMS WERE NOTED. HOWEVER, CORRODED KEYPAD TRACES WERE NOTED DURING THE VISUAL INSPECTION. THE INSULIN PUMP HAD A CRACKED DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP AND SCRATCHES ON THE RESERVOIR TUBE WINDOW. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, PRIME TEST AND EXCESSIVE NO DELIVERY ALARM TEST.

    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 RECEIVING A BUTTON ERROR ALARM ON THE INSULIN PUMP. CUSTOMER STATED THAT THE NUMBERS BEGUN FLASHING WHEN ATTEMPTING TO ENTER CARBS FOR DINNER. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 88 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683726 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR