BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTCLIX ® LANCETS

    MDR report key: 3013418 · Received March 20, 2013

    Report

    Report Number
    1823260-2013-01698
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    November 1, 1990
    Report Date
    July 29, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT HE RECEIVED MEDICAL TREATMENT FOR A LANCET STICK WHEN USING THE SOFTCLIX DEVICE AND LANCETS. CUSTOMER HAD AN INFECTION AT THE LANCET STICK SITE AND FINGER WAS SWOLLEN. CUSTOMER WENT TO THE ER AND WAS TREATED WITH A BENADRYL SHOT AND THEY SOAKED THE FINGER IN HYDROGEN PEROXIDE. FINGER IS CURRENTLY HEALED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116554 SOFTCLIX ® LANCETS LANCET FMK ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Required Intervention CPAP MACHINE| ELECTRIC WHEELCHAIR| T.E.N.S. UNIT| WALKER| WHEEL CHAIR| CPAP MACHINE| WALKER| WHEEL CHAIR| ELECTRIC WHEELCHAIR| T.E.N.S. UNIT