BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCELERATOR APS

    MDR report key: 1983887 · Received February 10, 2011

    Report

    Report Number
    1628664-2011-00067
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Report Date
    January 21, 2011
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND FOR THE ISSUE UNDER INVESTIGATION. CURRENT LABELING ADEQUATELY DESCRIBES CONFIGURATION PARAMETERS FOR BAR CODES AND SAMPLES AND ACCEPTABLE BAR CODE SPECIFICATIONS. AN INVESTIGATION WAS OPENED TO INVESTIGATE THE ISSUE OF BAR CODE LABELS BEING MISREAD AS 1-2 DIGIT SIDS AND CHARACTER SUBSTITUTIONS. (B)(4) WILL RELEASE A NEW BARCODE READER CONFIGURATION FILE AS AN ENHANCEMENT THAT WILL DEFINE THE DEFAULT MINIMUM SETTING AS FOUR AND THE MAXIMUM AS 24. A TECHNICAL SERVICE BULLETIN WAS ISSUED TO ENSURE THE PARAMETERS FOR THE BARCODE READERS ON THE IOM CENTRIFUGE AND I2000SR INSTRUMENT MODULE ARE UNIFORM AND THAT THEY ARE OPTIMIZED FOR THE SAMPLE BARCODES USED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A BARCODE MISREAD OCCURRED ON THE INPUT/OUTPUT MODULE (IOM) OF THE ACCELERATOR APS. (B)(6) WAS MISREAD AS (B)(6). AN ERROR, "NO LIS DATA" WAS GENERATED AS NO ORDERS EXISTED FOR THE MISREAD SID AND THE SAMPLE WAS NOT PROCESSED. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCELERATOR APS AUTOMATED SAMPLE HANDLING AND PROCESSING SYSTEM JQP ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1