BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4112229 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-94908
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ALL OF THE OPERATING CURRENTS ARE WITHIN SPECIFICATION. NO UNEXPECTED LOW BATTERY OR OFF NO POWER ALARMS WERE NOTED. THE INSULIN PUMP PASSED OFF NO POWER TEST, ERROR TEST, DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, AND EXCESSIVE NO DELIVERY ALARM TEST. THE DEVICE WAS RECEIVED WITH CRACKED AND BLEEDING LCD GLASS, CRACKED DISPLAY WINDOW CORNERS, MINOR SCRATCHED LCD WINDOW, AND CRACKED RESERVOIR TUBE LIP. THE FUNCTIONAL TEST, INCLUDING SELF TEST, WAS UNABLE TO BE COMPLETED DUE TO MINOR CRACKED AND BLEEDING LCD GLASS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED IN (B)(6) 2014 DUE TO LOW BLOOD GLUCOSE. SINCE THIS WAS A PAST EVENT THE CUSTOMER COULD NOT REMEMBER THE EXACT BLOOD GLUCOSE VALUE. THE CUSTOMER WAS ALSO REPORTING THAT THERE WAS BLUE INK INSIDE THE SCREEN OF THE INSULIN PUMP. THEY STATED THAT THE INK WAS SPILLING ACROSS THE SCREEN OF THE DEVICE MAKING IT IMPOSSIBLE FOR THE CUSTOMER TO READ THE DISPLAY. THE CUSTOMER STATED THAT THERE WAS A CRACK ON THE DISPLAY OF THE INSULIN PUMP. AT THE TIME OF THE PHONE CALL THE CUSTOMER'S BLOOD GLUCOSE WAS 130 MG/DL. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591601 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR