BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4131852 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31496
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 30, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD AN ARROW BUTTON THAT DID NOT RESPOND DUE TO CORRODED KEYPAD TRACES. NO SCROLLING NUMBERS DISPLAY ANOMALY NOTED. NO MOISTURE DAMAGE ON ELECTRONICS NOTED. NO DISCOLORATION ON SCREEN NOTED. INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE AND BLEEDING LCD.

    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

    IT WAS REPORTED THAT THE CUSTOMER SWEATS MORE THAN THE NORMAL PERSON. CUSTOMER NOTICED ABOUT THREE WEEKS AGO THAT THE SCREEN WAS DISCOLORED. CUSTOMER CANNOT SCROLL DOWN TO REWIND AND THE ARROW BUTTONS DO NOT WORK. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 427 MG/DL. CUSTOMER STATED THAT THE PUMP WAS NOT WORKING AT ALL. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612043 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR