BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® MULTICLIX LANCETS

    MDR report key: 3122401 · Received May 21, 2013

    Report

    Report Number
    1823260-2013-03078
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 16, 2013
    Report Date
    July 28, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    CALLER STATES THAT SHE STUCK HER FINGER ON (B)(6) 2013 WITH AN EXPIRED LANCET. CUSTOMER STATES HER FINGER WAS SWOLLEN ONE HOUR LATER AND HURT "REALLY BAD". CUSTOMER WENT TO HER DOCTOR'S APPOINTMENT ON (B)(6) 2013 AND WAS TOLD THAT HER FINGER WAS INFECTED. CUSTOMER WAS GIVEN ANTIBIOTICS AND WAS TOLD TO SOAK HER FINGER IN EPSOM SALT AND WATER. CUSTOMER STATES HER FINGER IS FEELING BETTER. REQUESTED RETURN OF SUSPECT DEVICE AND LANCETS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224459 ACCU-CHEK ® MULTICLIX LANCETS LANCET FMK ROCHE DIAGNOSTICS NA WP080070

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention| O