BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SOFTCLIX

    MDR report key: 6075460 · Received November 3, 2016

    Report

    Report Number
    1823260-2016-01720
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    October 21, 2016
    Report Date
    December 13, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED AS NOT PRODUCT WAS RETURNED FOR INVESTIGATION. NO INFORMATION WAS PROVIDED IN THE COMPLAINT THAT WOULD POINT TO A CAUSE FOR THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER'S DAUGHTER CALLED FOR ASSISTANCE RUNNING A BLOOD TEST ON THE CUSTOMER WITH THE CUSTOMER'S ACCU-CHEK SOFTCLIX DEVICE AND ACCU-CHEK SOFTCLIX LANCETS. THE CUSTOMER'S DAUGHTER INSERTED A NEW LANCET INTO THE DEVICE AND TWISTED THE LANCET CAP OFF. WHILE APPLYING THE DIAL CAP TO THE DEVICE, THE CUSTOMER'S DAUGHTER STATED IT WAS LOOSE. THE CUSTOMER'S DAUGHTER WAS ADVISED HOW TO PROPERLY ATTACH THE DIAL CAP TO THE DEVICE. SHE INDICATED THAT THE LANCET WAS PROTRUDING FROM THE END CAP OF THE DEVICE. UPON REMOVING THE DIAL CAP, THE CALLER STATED THAT THE LANCET WAS SEATED PROPERLY IN THE CARRIER. NO ADVERSE EVENT OCCURRED. THE CUSTOMER'S DAUGHTER DID NOT PROVIDE THE LOT NUMBER OF THE DEVICE, NOR THE LANCETS. THE LANCET DEVICE AND LANCETS WERE REQUESTED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726948 ACCU-CHEK SOFTCLIX LANCET DEVICE FMK ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1