BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4241813 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50104
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH BLANK DISPLAY DUE TO MOISTURE DAMAGE ON ELECTRONIC ASSEMBLY. THE INSULIN PUMP HAS MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ISSUES WITH THE INSULIN PUMP. CUSTOMER STATES THAT THEY HAVE MOISTURE IN THE WINDOW OF THE INSULIN PUMP. CUSTOMER ALSO STATES THAT THERE IS FLUID/MOISTURE EXPOSURE. THE BLOOD GLUCOSE READING IS 208 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724047 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR