BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX

    MDR report key: 1880227 · Received October 22, 2010

    Report

    Report Number
    1823260-2010-06330
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 28, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO FIRE DEVICE DUE TO A DEFECTIVE BUTTON. COULD NOT TEST TO SEE IF THE LANCET RETRACTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECHNICIAN, TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE CONSIDERABLY CALCIFIED COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AN ANTERIOR CUFF MISS OCCURRED. THE DEVICE WAS REMOVED AND ANOTHER PROGLIDE WAS USED WITH THE SAME RESULTS. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® MULTICLIX LANCET DEVICE FMK ROCHE DIAGNOSTICS NA WIT120

    Patients

    Seq Age Sex Outcome Treatment
    1