BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE

    MDR report key: 436516 · Received January 7, 2003

    Report

    Report Number
    436516
    Event Type
    Malfunction
    Date Received
    January 7, 2003
    Date of Event
    January 3, 2003
    Report Date
    January 6, 2003
    Manufacturer
    ROCHE
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE WAS USING ACCUCHECK LANCET PROPERLY. LANCET NEEDLE WAS INVERTED FROM THE MFR SUCH THAT NURSE GOT STUCK USING IT (NOT DIRTY). LOT PULLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROCHE ACCUCHECK SAFE-T-PRO FMK ROCHE DEPT 1.8 NDC NO 50924-951-20N

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other