BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT M2000

    MDR report key: 2698822 · Received December 16, 2011

    Report

    Report Number
    3005248192-2011-00033
    Event Type
    Malfunction
    Date Received
    December 16, 2011
    Date of Event
    November 16, 2011
    Report Date
    November 16, 2011
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JJH
    PMA / PMN Number
    K092705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ABBOTT MOLECULAR WILL ISSUE A CUSTOMER LETTER TO CUSTOMERS WHO RECEIVED THE NEW BAR CODE SCANNER USER'S GUIDES TO NOTIFY THEM OF THE INCORRECT LANGUAGE CONFIGURATION BAR CODES AND PROVIDE A CORRECT VERSION OF THE AFFECTED SECTIONS IN THE USER'S GUIDES. .

    Description of Event or Problem · 1

    THIS ISSUE WAS DISCOVERED INTERNALLY BY A (B)(6) ENGINEER. LANGUAGE CONFIGURATION BAR CODES - INTENDED USE: THE BARCODE SCANNER IS A HAND-HELD DEVICE THAT PROVIDES CONVENIENT MEANS OF SCANNING SAMPLE BAR CODES TO ALLOW POSITIVE SAMPLE IDENTIFICATION AND IS SUPPLEMENTARY TO THE COMPUTER KEYBOARD. BOTH THE SCANNER AND THE KEYBOARD TRANSMIT DATA TO A SYSTEM CONTROL CENTER (SCC) THROUGH A SINGLE WEDGE (CABLE WITH BRANCHED CONNECTORS). THE BARCODE SCANNER MUST BE CONFIGURED TO MATCH THE KEYBOARD LANGUAGE BEING USED. IN ITS DEFAULT CONFIGURATION SET BY THE MFR (JADAK), THE SCANNER IS IN ENGLISH FORMAT. IF A KEYBOARD OTHER THAN THE ENGLISH KEYBOARD IS BEING USED, THE USER IS REQUIRED TO USE THE SCANNER TO SCAN AN APPROPRIATE LANGUAGE CONFIGURATION BARCODE PROVIDED IN THE USER'S GUIDE TO MATCH THE LANGUAGE OF THE KEYBOARD. USERS IN THE U.S HAVE THE ABILITY TO CONVERT TO ANOTHER LANGUAGE. BARCODE SCANNER USER'S GUIDES IN 7 LANGUAGES [LIST NUMBERS (LN) 06L88-03, 06K88-04,... 06L88-09] WERE RELEASED ON (B)(6) 2011, CONCURRENTLY WITH THE RELEASE OF SCC 1D BARCODE SCANNER (LN 06L89-03; NEW 1D SCANNER) AND SCC 2D BARCODE SCANNER (LN 06L89-02; 2D SCANNER). THESE USER'S GUIDES CONTAIN SECTIONS FOR THE TWO NEWLY RELEASED SCANNERS AS WELL AS SECTIONS FOR THE PREVIOUSLY RELEASED SCC 1D BAR CODE SCANNER (LN 06L89-01; OLD 1D SCANNER). SOME LANGUAGE CONFIGURATION BAR CODES ARE INCORRECT IN THE SECTION FOR THE PREVIOUSLY RELEASED SCC BAR CODE SCANNER (LN 06L89-01). IMPACT OF DEFICIENCY ON PRODUCT FUNCTIONALITY: THE IMPACT IS LIMITED TO THE OLD 1D SCANNER USERS ONLY. OLD 1D SCANNERS WERE SOLD SINCE 2006 AND STARTED BEING PHASED OUT FROM ABBOTT MOLECULAR INVENTORY SINCE JUL 2011 WHEN IT REACHED END OF LIFE AT THE MFR, JADAK. EACH OLD 1D SCANNER IS PACKED WITH THE EARLIER VERSION OF THE USER'S GUIDE (LN 06L88-02) WHICH WAS IN ENGLISH ONLY AND HAD NO ERROR IN THE LANGUAGE CONFIGURATION BAR CODES. AMONG THE 5 KEYBOARDS OF VARIOUS LANGUAGES SUPPORTED BY THE OLD 1D SCANNER, THERE IS NO DIFFERENCE IN THE NUMERIC CHARACTERS (0,1,2,..,9). THEREFORE NUMERIC SAMPLE IDS ARE NOT AFFECTED. IF A USER DECIDES TO USE THE NEW USER'S GUIDE FOR AN OLD 1D SCANNER, THE INCORRECT LANGUAGE CONFIGURATION BAR CODES IN THE NEW GUIDE WILL HAVE THE FOLLOWING IMPACTS: THE INCORRECT LANGUAGE CONFIGURATION BAR CODES REDUCE THE USER'S CAPABILITIES FOR THE LANGUAGE CONFIGURATION. WHEN AN INCORRECT LANGUAGE CONFIGURATION BAR CODE IS SCANNED, NO TONE WILL BE HEARD, WHICH INDICATES THAT THE SCAN MUST BE REPEATED. THE USER WILL REALIZE THAT THE CHANGE OF LANGUAGE CONFIGURATION WAS NOT SUCCESSFUL. USERS WHO ATTEMPT TO USE THE BAR CODE READER WITH THIS ERROR COULD TRANSMIT INCORRECT SAMPLE IDS. THE USER'S GUIDES IN SEVEN LANGUAGES ARE SOLD AS INDIVIDUAL LANGUAGE VERSIONS, THEY ARE PACKED WITH EACH NEW 1D SCANNER OR 2D SCANNER PRODUCT, OR THEY ARE AVAILABLE FROM THE GSS WEBSITE THROUGH ABBOTT PERSONNEL. THE NEW 1D SCANNERS AND 2D SCANNERS ARE NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT M2000 STATION, PIPETTING AND DILUTING, FOR CLINICAL USE JJH ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1