BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1181530 · Received September 25, 2008

    Report

    Report Number
    1823260-2008-07144
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 20, 2008
    Report Date
    September 25, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT THE LANCET DOES NOT RETRACT BACK INTO THE CAP OF THE ACCU-CHEK SOFTCLIX LANCET DEVICE AFTER FIRING. NO ACTION TAKEN OR TREATMENT GIVEN BASED ON THE LANCET DEVICE ISSUE. THE REPORTER STATES THAT THE CORRECT LANCETS WERE USED. SHE ALSO STATES THAT SHE WAS UNSURE IF THE LANCET WAS SEATED PROPERLY. NO ACCIDENTAL STICKS OR ADVERSE EVENT REPORTED. THE CUSTOMER DISCARDED THE LANCETS AND LANCET DEVICE. THE SUSPECTED PRODUCT IS UNAVAILABLE FOR RETURN; REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTCLIX LANCET DEVICE LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR HUMULIN 70/30 - SEVERAL YEARS| "DIOBAN" - 2 YEARS| LANTUS - SEVERAL YEARS