BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2771113 · Received October 3, 2012

    Report

    Report Number
    3004209178-2012-89881
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    August 24, 2012
    Report Date
    September 25, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH BLANK DISPLAY AS A RESULT OF A BROKEN SOLDER JOINT COMPONENT ON THE INTERFACE BOARD. THE DEVICE ALSO HAD A LOOSE DRIVE SUPPORT DISK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. TROUBLESHOOTING WAS PERFORMED. INSTRUCTED THE CALLER TO REMOVE THE BATTERY FOR TEN MINUTES, BUT THE DEVICE HAD A BATTERY ALARM. ADVISED THE CUSTOMER THAT THE DEVICE WILL BE REPLACED AND REVERT TO BACK UP PLAN. THE BLOOD GLUCOSE READING WAS 132MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR