BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1771105 · Received February 5, 2008

    Report

    Report Number
    1823260-2008-01207
    Event Type
    Malfunction
    Date Received
    February 5, 2008
    Date of Event
    January 10, 2008
    Report Date
    February 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    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 PRIMING/FIRING. NO ACTION TAKEN OR TREATMENT GIVEN BASED ON THE LANCET DEVICE ISSUE. HE WAS ACCIDENTALLY STUCK BUT DID NOT REQUIRE MEDICAL ATTENTION. NO ADVERSE EVENT REPORTED. NEW LANCET DEVICE WITH LANCETS SENT AND RETURN REQUESTED. THE REPORTER STATES THAT HE DISCARDED THE LANCET DEVICE BUT WILL RETURN THE LANCETS.

    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 53 YR CYMBALTA - 90MG/DAY - 6-7 MONTHS| KLONOPIN - 10MG/DAY - 5 YEARS| VYTORIN - 10/80 1/DAY - 3.5 YEARS| HUMALOG INSULIN PUMP - 4 YEARS| LAMICTAL - 250MG/DAY - 5 YEARS| TYSABRI IV - MONTHLY (DOCTOR) -1 YEAR| NITROQUICK - 4MG/PRN - 10/05| BABY ASPIRIN - 81MG/DAY - 4 YEARS| RENEXIA - 1000MG/DAY - 1 YEAR| NIASPAN - 500MG/DAY - 4 YEARS| ATENOLOL - 25MG/DAY - 4 YEARS| ENALAPRIL - 2.5 MG/DAY - 4 YEARS| NEXIUM - 20MG/DAY - 10/05| NORVASC - 10MG/DAY - 10/05| PLAVIX - 75MG/DAY - 10/05| TRAZODONE - 150MG/1-2/DAY - 6-7 MONTHS| SYNTHROID - 150MG/DAY - 10 YEARS