BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX ® LANCETS

    MDR report key: 3932861 · Received July 14, 2014

    Report

    Report Number
    1823260-2014-05221
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 15, 2014
    Report Date
    July 28, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THE CUSTOMER RETURNED ONE UNUSED LANCET FROM LOT X246004. THE UNUSED LANCET WAS INSPECTED AND NO NON-CONFORMITIES WERE FOUND. BECAUSE THE LANCET THAT ALLEGEDLY LEFT A FRAGMENT IN THE CUSTOMER'S FINGER WAS NOT RETURNED, IT WAS NOT POSSIBLE TO EVALUATE THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CALLER STATES A PIECE OF THE SOFTCLIX LANCET BROKE OFF IN HIS FINGER. NO MEDICAL TREATMENT REQUIRED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410422 SOFTCLIX ® LANCETS LANCET FMK ROCHE DIAGNOSTICS NA X246004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male