BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2110278 · Received May 20, 2011

    Report

    Report Number
    2183996-2011-01434
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 25, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THE DISPLAY ON HIS INFUSION DEVICE IS DAMAGED. PT STATED ABOUT A 1/3 OF THE SCREEN IS DARK BLUE AND HE CAN BARELY SEE THE BASAL RATE. PT REPORTED THE TOP HALF OF THE SCREEN IS BLANK AND 1/3 OF THE DISPLAY ON THE LEFT SIDE IS DARK BLUE WITH A "CLEAR" SPOT IN THE MIDDLE. PT STATED HE NORMALLY HAS 0.7 UNITS FOR HIS BASAL RATE AND HE CAN SEE LESS THAN HALF OF THE ZERO AND THE BOTTOM HALF OF 7. PT REPORTED HE NOTICED THIS ISSUE YESTERDAY. PT STATED THE INFUSION DEVICE DISPLAYED THE AUTOMATIC OFF ALARM BECAUSE HE HAD NOT TOUCHED ANY BUTTONS IN OVER 12 HOURS. PT REPORTED IT WAS NORMAL FOR IT TO ALARM LIKE THIS. PT STATED WHEN HE WENT TO SILENCE THE ALARM; HE NOTICED THE ISSUE WITH THE DISPLAY. VERIFIED THE INFUSION DEVICE WAS NOT DROPPED AND DID NOT HIT ANYTHING. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PROD WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PROD FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR INSULIN| INSULIN INFUSION SET