BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 1021769 · Received March 20, 2008

    Report

    Report Number
    1823260-2008-02614
    Event Type
    Malfunction
    Date Received
    March 20, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 20, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE RPTR INITIALLY CALLED TO STATE THAT THE LANCET WILL NOT COME DOWN TO STICK HER FINGER AND THE PLUNGER BUTTON WILL NOT STAY DOWN. SHE STATES THAT SHE REC'D AN ACCIDENTAL STICK AFTER RETRIEVING THE LANCET FROM THE ACCU-CHEK SOFTCLIX LANCET DEVICE. NO MEDICAL ATTN REQUIRED. THE RPTR ALSO STATES THAT THE LANCET DEVICE DOES NOT RETRACT BACK INTO THE CAP OF THE ACCU-CHEK SOFTCLIX PLUS LANCET DEVICE AFTER FIRING. THE RPTR DISCOVERED THIS DURING THE CALL TO THE ACCU-CHEK CUSTOMER CARE SVC CTR AGENT. NO ACTION TAKEN OR TREATMENT GIVEN BASED ON THE LANCE DEVICE ISSUE. NO ADVERSE EVENT REPORTED. NEW LANCED DEVICE WITH LANCETS SENT AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTCLIX PLUS LANCET DEVICE LANCET DEVICE -FMK FMK ROCHE DIAGNOSTICS BAT028

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR LIPITOR 20MG/DAY 9 YRS| ACTOS 30MG/DAY 2 YRS| LANTUS 6 UNITS/DAY 1 YR| AMARYL 4 MG/DAY 2 YRS| GLUCOPHAGE 1000 MG/DAY 4 YRS| AVONEX 30MCG/WEEK 12 YRS| PRINIVIL 20 MG/DAY - 4 YRS