BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAR CODE SCANNER SCC

    MDR report key: 1527059 · Received November 12, 2009

    Report

    Report Number
    3005248192-2009-00004
    Event Type
    Other
    Date Received
    November 12, 2009
    Date of Event
    October 15, 2009
    Report Date
    November 12, 2009
    Manufacturer
    JADAK
    Product Code
    NZH
    PMA / PMN Number
    BP060002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD CORRECTION LETTER (PER FA-CAM-NOV2009-066) WAS SENT OUT TO ABBOTT MOLECULAR CUSTOMERS INFORMING THEM TO BE SURE THAT THE CAPS LOCK FEATURE WAS NOT ENABLED OR ANY OTHER ADDITIONAL KEYBOARD KEYS (SUCH AS THE SHIFT KEY) WHEN USING THE HAND-HELD BAR CODE SCANNER. THE CUSTOMERS WERE ALERTED TO THE FACT THAT THE M2000 INSTRUMENT SYSTEM MAY NOT BE ABLE TO TRACK THE SAMPLE IDENTIFICATION FOR PT SAMPLES, CALIBRATORS AND CONTROLS CORRECTLY. THEY WERE INFORMED THAT THERE IS NO IMPACT TO PT RESULTS; HOWEVER, THIS ISSUE COULD RESULT IN MISIDENTIFICATION OF PT SAMPLE ID.

    Description of Event or Problem · 1

    WHEN THE HAND-HELD BAR CODE SCANNER IS USED FOR ENTERING (SCANNING) DATA UNDER CONDITION THAT THE COMPUTER KEYBOARD CAPS LOCK KEY IS ENABLED, UPPER CASE LETTERS ENCODED IN THE BAR CODES WILL BE REPORTED BY THE COMPUTER AS LOWER CASE ONES, AND LOWER CASE LETTERS WILL BE REPORTED AS UPPER CASE ONES. WHEN THE HAND-HELD BAR CODE SCANNER IS USED FOR ENTERING DATA UNDER CONDITION THAT SOME OTHER KEYBOARD KEYS ARE ENABLED, DATA SCANNED CAN BE ALTERED SUCH THAT THOSE RECOGNIZED BY THE M2000 SCC MAY NOT MATCH THE CODES CONTAINED ON THE BAR CODE FOR ALL CASES. THERE IS IMPACT TO PRODUCT FUNCTIONALITY, SUCH THAT THE SYSTEM MAY NOT TRACK THE SAMPLE IDENTIFICATION CORRECTLY FROM SAMPLE INPUT TO REPORTED RESULTS WHEN THE ISSUE AS DESCRIBED ABOVE OCCURS. THIS ISSUE MAY RESULT IN PT SAMPLE IDENTIFICATION MISMATCH, WITH A HAZARD OF INCORRECT RESULTS REPORTED. ADDITIONALLY, IT MAY CAUSE A DELAY OF ONE DAY IF THE SCANNER ISSUE OCCURS ON A CALIBRATOR OR CONTROL. OVERALL RISK IS LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAR CODE SCANNER SCC BAR CODE SCANNER NZH JADAK 06L89-01 ALL

    Patients

    Seq Age Sex Outcome Treatment
    1