BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® FASTCLIX LANCETS

    MDR report key: 3232611 · Received July 18, 2013

    Report

    Report Number
    1823260-2013-04320
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    May 20, 2013
    Report Date
    July 28, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THE YEAR IS THE ONLY KNOWN PART OF MANUFACTURE DATE. WE HAVE DEFAULTED TO THE FIRST OF THE YEAR.

    Description of Event or Problem · 1

    REPORTER STATED FOR THE PAST 5 WEEKS CUSTOMER HAD BEEN PRICKING HIS FINGER WITH THE FASTCLIX DEVICE AND IT WAS VERY PAINFUL. THE TIP FROM THE LANCET WAS STUCK IN THE PAD OF HIS RIGHT FOREFINGER. AFTER APPROXIMATELY 3 WEEKS THE CUSTOMER WENT TO HIS DOCTOR BECAUSE HIS FINGER HURT AND WAS SWOLLEN. AN X-RAY WAS TAKEN. IT WAS DISCOVERED THAT THE TIP FROM THE LANCET WAS STUCK BETWEEN THE SECOND AND THIRD PHALANX. ON (B)(6) 2013 THE LANCET TIP WAS SURGICALLY REMOVED. ON (B)(6) 2013 THE STITCHES WERE REMOVED. THE CUSTOMER IS DOING WELL ALTHOUGH HE STILL HAS A LITTLE PAIN. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334594 ACCU-CHEK ® FASTCLIX LANCETS LANCET FMK ROCHE DIAGNOSTICS NA WPB004

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention UNSPECIFIED INSULIN| UNSPECIFIED INSULIN