BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4993281 · Received August 11, 2015

    Report

    Report Number
    2032227-2015-27422
    Event Type
    Injury
    Date Received
    August 11, 2015
    Date of Event
    July 19, 2015
    Report Date
    July 19, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    BUTTON ERROR ALARM AND NO ESC BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. UNABLE TO PERFORM FUNCTIONAL CHECK INCLUDING REWIND AND BASIC OCCLUSION, OCCLUSION, PRIME/DELIVERY, THE EXCESSIVE NO DELIVERY, DISPLACEMENT, SELF TEST, UNEXPECTED RESTART TEST AND ALL OPERATING CURRENT TEST DUE TO NO ESC BUTTON RESPONSE. PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BUTTON ERROR ALARM. THE CUSTOMER REPORTED THAT SHE HAD THE DEVICE IN HER BRA WHILE WORKING IN THE YARD. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 50 MG/DL. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527548 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention