BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTCLIX ® LANCETS

    MDR report key: 3021750 · Received March 26, 2013

    Report

    Report Number
    1823260-2013-01850
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 4, 2013
    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
    VA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    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 HAD BEEN USING THE SAME SOFTCLIX LANCET FOR AT LEAST A MONTH. CUSTOMER WAS DIAGNOSED WITH (B)(6) ABOUT (B)(6) WEEKS AGO AND SPENT TWO WEEKS IN THE HOSPITAL. CUSTOMER TESTED (B)(6) FOR (B)(6) IN HIS BLOOD AND WAS TREATED WITH AN IV IN THE HOSPITAL (TREATMENT AND CONTENTS NOT PROVIDED). CUSTOMER ALLEGEDLY CONTRACTED (B)(6) DUE TO NOT CHANGING THE LANCET IN HIS SOFTCLIX DEVICE. CUSTOMER HAS AN OPEN ULCER ON HIS FOOT. CUSTOMER IS DOING FINE NOW. CUSTOMER WAS USING THE EXPIRED LANCET AT THE TIME OF THE INCIDENT. CUSTOMER IS UNABLE TO RETURN THE SOFTCLIX LANCING DEVICE, AS IT WAS DISCARDED. REQUESTED RETURN OF THE SUSPECT LANCET NEEDLES, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123519 SOFTCLIX ® LANCETS LANCET FMK ROCHE DIAGNOSTICS NA J338311

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Hospitalization METFORMIN| METFORMIN