BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® MULTICLIX LANCETS

    MDR report key: 2629603 · Received June 26, 2012

    Report

    Report Number
    1823260-2012-03338
    Event Type
    Injury
    Date Received
    June 26, 2012
    Date of Event
    June 1, 2011
    Report Date
    June 26, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CALLER STATES HE GOT AN INFECTION IN HIS LEG DUE TO USING THE SAME MULTICLIX LANCET REPEATEDLY. A PHYSICIAN NOTICED THAT THE CALLER'S LEG WAS SWOLLEN AND RED; THE PHYSICIAN PRESCRIBED KEFLEX AND A COMPRESSION SOCK FOR THE CALLER. CALLER'S INFECTION IMPROVED AFTER 10 DAYS OF ANTIBIOTICS AND 2 WEEKS OF WEARING THE COMPRESSION SOCK. REQUESTED RETURN OF SUSPECT DEVICE HOWEVER CALLER NO LONGER HAS THE LANCET DRUM; REPLACEMENT WAS SENT.

    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
    1 059 YR Required Intervention METFORMIN| GLIPIZIDE