BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX

    MDR report key: 1842778 · Received September 23, 2010

    Report

    Report Number
    1823260-2010-05648
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 31, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CALLER REPORTS LANCET PROTRUDES BEYOND THE END CAP OF THE MULTICLIX DEVICE. NO ACCIDENTAL NEEDLE STICK OCCURRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    (B)(6). THIS DEVICE CASE, WHICH DOES NOT INVOLVE AN ADVERSE EVENT, REPORTED BY A PHARMACY WHO CONTACTED THE COMPANY WITH A PRODUCT COMPLAINT, CONCERNS A PATIENT OF UNKNOWN AGE, GENDER, OR ORIGIN. THE PATIENT WAS TAKING AN UNSPECIFIED MEDICATION FOR TREATMENT OF AN UNKNOWN INDICATION. ON (B)(6) 2010, THE HUMAPEN MEMOIR BURGUNDY DEVICE REPORTEDLY COULD NOT BE SET BY TURNING AND PRESSING THE KNOB. THIS HUMAPEN MEMOIR BURGUNDY DEVICE WAS ASSOCIATED WITH PRODUCT COMPLAINT (B)(4), LOT 0903C04. THE RETURNED DEVICE WAS FOUND TO BE IN RESET; HOWEVER PART OF THE RIGHT HAND STRIPES IN THE DOSE DIGITS WAS MISSING. THE OPERATOR OF THE DEVICE WAS UNKNOWN. IT WAS UNKNOWN IF THE USER WAS TRAINED. THIS DEVICE MODEL WAS USED FOR AN UNSPECIFIED LENGTH OF TIME. THE DEVICE WAS RETURNED ON (B)(6) 2010. THE HUMAPEN MEMOIR BURGUNDY DEVICE WAS NOT CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® MULTICLIX LANCET DEVICE FMK ROCHE DIAGNOSTICS NA GWW090

    Patients

    Seq Age Sex Outcome Treatment
    1 056 YR