BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK MULTICLIX LANCETS

    MDR report key: 1241188 · Received November 20, 2008

    Report

    Report Number
    1823260-2008-08642
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 30, 2008
    Report Date
    November 20, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    RPTR ALLEGED THAT THE CUSTOMER USED THE SAME MULTICLIX LANCET IN HER MULTICLIX DEVICE FOR A WEEK AND HER FINGERS TURNED BLACK AND BLUE. RPTR STATED HE TOOK THE CUSTOMER TO THE HOSPITAL AFTER SHE OBTAINED A READING IN THE 50-69 MG/DL RANGE AND SELF-TREATED WITH JUICE. RPTR STATED SHE WAS TREATED AT THE HOSPITAL WITH AN ANTIBIOTIC FOR AN E-COLI INFECTION WHICH ALSO DEVELOPED IN HER CHEST AND ABDOMEN. RPTR STATED THAT WHILE THERE, SHE WAS ALSO TREATED WITH INSULIN AND A F/U APPOINTMENT WAS SCHEDULED WITH HER DR. NO OTHER TREATMENT RESULTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PROD WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK MULTICLIX LANCETS LANCET - FMK FMK ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R HUMALOG 75/25 - 1 YEAR