BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SOFTCLIX

    MDR report key: 1915829 · Received December 6, 2010

    Report

    Report Number
    1823260-2010-07179
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 14, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    MANUFACTURER'S INVESTIGAION LAB REPORTS LANCET PROTRUDES BEYOND THE END CAP OF THE SOFTCLIX DEVICE. NO ADVERSE EVENT REPORTED. DEVICE HAD BEEN RETURNED, REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SOFTCLIX LANCET DEVICE FMK ROCHE DIAGNOSTICS NA WIM069

    Patients

    Seq Age Sex Outcome Treatment
    1