BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX

    MDR report key: 1680876 · Received May 12, 2010

    Report

    Report Number
    1823260-2010-02864
    Event Type
    Malfunction
    Date Received
    May 12, 2010
    Date of Event
    May 10, 2010
    Report Date
    May 26, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 AFTER FIRING. NO ACCIDENTAL NEEDLE STICK OCCURRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE, AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    WHEN A CERNER SERVICE PACK WAS LOADED INTO OUR SYSTEM IN MARCH , THE CONTENTS OF THE PACKAGE ADVERSELY AFFECTED THE BLOOD BANK'S ABILITY TO USE THE "PATIENT PRODUCT INQUIRY" FUNCTION (PPI). PPI IS USED BY THE BLOOD BANK TO PERFORM A NUMBER OF PROCESSES, MOST IMPORTANTLY A LISTING OF PATIENT'S TRANSFUSION HISTORY. WITH THIS DEFECT ,WHEN PPI IS SELECTED, THE COMPUTER FREEZES UP AND EVENTUALLY GIVES US AN ERROR MESSAGE. NOT HAVING THE ABILITY TO USE THIS FUNCTION LIMITS THE BLOOD BANK'S ABILITY TO VIEW RECENT TRANSFUSION HISTORY, AS WELL AS BLOOD TYPE, ANTIBODIES, AND OTHER CRUCIAL BLOOD BANK INFORMATION. SOME, BUT NOT ALL, OF THIS INFORMATION CAN BE LOCATED USING OTHER FUNCTIONS, WITH THE MAJOR EXCEPTION OF RECENT TRANSFUSION HISTORY. WHILE THE SCREEN IS FROZEN, WE ARE UNABLE TO USE OTHER CERNER BLOOD BANK FUCNTIONS. IN ADDITION, AT TIMES, WE HAVE HAD MULTIPLE COMPUTER TERMINALS TIED UP AND UNAVAILABLE FOR USE UNTIL THESE SCRIPT ERRORS TIME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® MULTICLIX LANCET DEVICE FMK ROCHE DIAGNOSTICS NA GWX016

    Patients

    Seq Age Sex Outcome Treatment
    1