BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SOFTCLIX

    MDR report key: 2100932 · Received May 24, 2011

    Report

    Report Number
    1823260-2011-02754
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 28, 2011
    Report Date
    November 11, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). OTHER : NA.

    Description of Event or Problem · 1

    CALLER REPORTED LANCET PROTRUDING FROM SOFTCLIX DEVICE CAP. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE DEVICE AND LANCETS, REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® SOFTCLIX LANCET DEVICE FMK ROCHE DIAGNOSTICS NA BAS011

    Patients

    Seq Age Sex Outcome Treatment
    1 039 YR