BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4191279 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41557
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED DISPLACEMENT TEST, OPERATING CURRENTS, SELF TEST AND OFF NO POWER TEST. NO BLANK DISPLAY NOTED. UNIT WAS MONITORED AND NO MISSING SEGMENT DURING TESTING. UNIT RECEIVED CRACKED CASE AT DISPLAY WINDOW CORNER.

    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

    (B)(6): CUSTOMER SAID THAT THE PUMP SCREEN WAS BLANK BUT WHEN SHE PRESSED THE BUTTON FOR AN EASY BOLUS IT SCREEN WOULD COME BACK ON BUT THER WOULD BE BLACK LINES WHERE THE NUMBER WAS SUPPOSED TO BE. INQUIRED WHAT LED UP TO THE COMPLAINT. CUSTOMER RESPONSE: SCREEN BLANK, BLANK DISPLAY T/S PER DOP. PATIENT'S BG IS 217 MG/DL. EXPLAINED THE POSSIBLE CAUSES OF BLANK DISPLAY. ADV TO DISCONNECT FROM THE PUMP. CUSTOMER IS NOT CALLING BACK AFTER RECEIVING A NEW BATTERY CAP. INQUIRED...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669515 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-723RNAB A000290053

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR