BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2172386 · Received June 17, 2011

    Report

    Report Number
    2183996-2011-01773
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 30, 2011
    Report Date
    May 30, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    Z-1415-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT'S WIFE CALLING REGARDING THE UP/DOWN BUTTON RECALL. PT'S WIFE REPORTED, THE PT WAS HOSPITALIZED EARLIER THIS YEAR FROM (B)(6) 2011. WIFE STATED, THIS WAS DUE TO THE PT EXPERIENCING A HEART ATTACK AND LATER LOSING HIS VISION. WIFE REPORTED, THE PT HAS NOT BEEN USING HIS INFUSION DEVICE SINCE BEFORE THAT TIME DUE TO DR'S ORDERS. WIFE STATED, THE PT HAS NOT EXPERIENCED ANY CONCERNS OR ISSUES WITH THE UP/DOWN BUTTONS. AT THE TIME OF THE CALL, THE INFUSION DEVICE DID NOT BEEP/VIBRATE WHEN THE UP/DOWN BUTTONS ARE PRESSED. WIFE REPORTED, THE BUTTONS DID POP BACK UP WHEN PRESSED. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT 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 53 YR INSULIN| INSULIN INFUSION SET