BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX LANCETS

    MDR report key: 3232128 · Received July 17, 2013

    Report

    Report Number
    1823260-2013-04304
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 20, 2013
    Report Date
    July 29, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THE YEAR IS THE ONLY KNOWN PART OF MANUFACTURE DATE. WE HAVE DEFAULTED TO THE FIRST OF THE YEAR.

    Description of Event or Problem · 1

    CALLER STATES THAT THE MULTICLIX DRUM WAS UNCAPPED OUT-OF-BOX. CUSTOMER PICKED UP THE DRUM AND TWO LANCET NEEDLES FELL OUT OF THE DRUM. CUSTOMER MENTIONED THAT WHEN PURCHASED, THE BOX OF THE DRUM WAS DAMAGED WITH "RAZOR CUTS" PRIOR TO BEING OPENED. NO ACCIDENTAL NEEDLESTICK OCCURRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330669 ACCU-CHEK ® MULTICLIX LANCETS LANCET FMK ROCHE DIAGNOSTICS NA WP120001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown