BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® MULTICLIX LANCETS

    MDR report key: 1903825 · Received November 20, 2010

    Report

    Report Number
    1823260-2010-06889
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    August 4, 2010
    Report Date
    November 19, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT THE CUSTOMER WAS USING THE MULTICLIX LANCET DEVICE ONLY ON HER RIGHT HAND AND SOON AFTER, SHE STARTED TO HAVE PAIN. REPORTER STATED THAT SOME TIME AFTER THAT, THE RIGHT HAND STARTED TO SWELL AND THEY SOUGHT MEDICAL TREATMENT. REPORTER STATED THE CUSTOMER WAS PUT ON A HIGH POTENT ANTIBIOTIC TO TREAT HER FOR EITHER BLOOD POISONING OR AN INFECTION THOUGHT TO BE CAUSED BY THE LANCET NEEDLE IN THE DEVICE. NO OTHER ACTION OR TREATMENT RESULTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEVEMIR| APIDRA