BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2932115 · Received January 18, 2013

    Report

    Report Number
    2183996-2013-00054
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    January 9, 2013
    Report Date
    April 18, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCTION DATA SHOWS NO DEVIATIONS OF THE SPECIFICATIONS. RESULT AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE PRODUCTION DATA COMPLY WITH THE SPECIFICATION, THE COMPLAINT COULD NOT BE REPLICATED. PRODUCTION REPORTS WERE REVIEWED. AS THE PRODUCT HAS NOT RETURNED FOR EVALUATION, THE COMPLAINT COULD NOT BE INVESTIGATED. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 PT REPORTED THE SCREEN OF THE INFUSION DEVICE HAS A BLACK SPOT ON THE DISPLAY. PT STATED THE SCREEN IS NOT DAMAGED. PT REPORTED THE BLACK DOT IS COVERING PART OF THE INSULIN AMOUNT BEING DELIVERED. PT STATED HE SHOULD BE SEEING A BASAL RATE OF 3.9 UNITS/HOUR RIGHT NOW BUT ALL HE CAN SEE IS THE 9. PT REPORTED THE BLACK SPOT IS ALSO AFFECTING THE TIME AND DATE AREA. HAD PT CHANGE TO A NEW BATTERY; THE LARGE BLACK POST IS STILL THERE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28575 ACCU-CHEK SPIRIT LZG ROCHE HEALTH SOLUTIONS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES