BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK MULTICLIX LANCETS

    MDR report key: 1062123 · Received June 18, 2008

    Report

    Report Number
    1823260-2008-04799
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 18, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT WHILE INSERTING A MULTICLIX LANCET DRUM INTO HER MULTICLIX LANCET DEVICE, SHE STUCK HERSELF WITH A LANCET THAT PROTRUDED. REPORTER STATED THAT PART OF THE LANCET NEEDLE BROKE OFF INTO HER FINGER AND SHE WENT TO THE DOCTOR TO HAVE IT REMOVED. REPORTER STATED THE DOCTOR ALSO BANDAGED HER FINGER. NO OTHER ACTION OR TREATMENT RESULTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK MULTICLIX LANCETS LANCET - FMK FMK ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention