BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1657831 · Received April 9, 2010

    Report

    Report Number
    2183996-2010-00694
    Event Type
    Malfunction
    Date Received
    April 9, 2010
    Date of Event
    March 15, 2010
    Report Date
    March 18, 2010
    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
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED AN ABNORMAL NOISE EMITTED FROM THE INFUSION DEVICE DURING BASAL DELIVERY. PT DESCRIBED THE NOISE AS A "CHICK-CHICK" SOUND EVERY COUPLE OF MINUTES. PT STATED THIS NOISE WAS NOT THE NORMAL SOUND EMITTED DURING INSULIN DELIVERY AND WAS LOUD ENOUGH TO DISTURB PEOPLE SITTING NEAR HER. HAD PT INSERT A NEW BATTERY; THE ABNORMAL NOISE CONTINUED. PT REPORTED SHE CHANGED THE INFUSION SETS AND INSULIN CARTRIDGES SEVERAL TIMES IN AN ATTEMPT TO FIX THE PROBLEM. ASSISTED THE PT WITH SETTING THE CORRECT TIME. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.

    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 52 YR INSULIN| INSULIN INFUSION SET