BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX

    MDR report key: 2021886 · Received March 17, 2011

    Report

    Report Number
    1823260-2011-01447
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    March 10, 2011
    Report Date
    April 20, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER REPORTS LANCET PROTRUDES BEYOND THE END CAP OF THE MULTICLIX DEVICE. CALLER WAS PRIMING THE DEVICE AND PRESSED THE RELEASE BUTTON. THE LANCET STUCK HER FINGER AND DID NOT RETRACT BACK INTO THE DEVICE. THE NEEDLE DID NOT BREAK OFF IN HER FINGER. NO ADVERSE EVENT OR MEDICAL ATTENTION NEEDED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® MULTICLIX LANCET DEVICE FMK ROCHE DIAGNOSTICS NA WPW170

    Patients

    Seq Age Sex Outcome Treatment
    1