BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCELERATOR APS

    MDR report key: 1935782 · Received December 22, 2010

    Report

    Report Number
    1628664-2010-00501
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 28, 2010
    Report Date
    November 29, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION TEAM REVIEWED THE CUSTOMER'S ISSUE THAT THE RESULTS GENERATED FOR A SAMPLE PRESENTED ON THE ACCELERATOR APS WERE ACTUALLY ASPIRATED FROM THE FOLLOWING SAMPLE. THE FIRST SAMPLE WAS RELEASED FROM THE ASPIRATION POINT AND SAMPLE #2 WAS MOVED INTO POSITION, AND TESTS WERE ASPIRATED. REVIEW OF THE MESSAGE HISTORY ON THE ARCHITECT I2000SR DID NOT REVEAL ANY ERROR CODE 8275 MESSAGES (SAMPLE PRESENTATION ERROR) AT THE TIME OF THE ISSUE. THE NECESSARY FILES IN THE APS HISTORY HAD ALREADY BEEN REPLACED WHEN THEY WERE REVIEWED, THEREFORE, NO ERROR MESSAGES COULD BE CONFIRMED. BASED ON THE DESCRIPTION OF THE ISSUE, THE INVESTIGATION TEAM DETERMINED THAT THE APS LIKELY GENERATED ERROR MESSAGE W 025, SAMPLE PRESENTATION ERROR, ON THE FIRST SAMPLE, AND W 026, SAMPLE QUEUE ERROR, ON THE SECOND SAMPLE. THE INSTRUMENT MANAGER MIDDLEWARE IS CONFIGURED TO PREVENT RELEASING RESULTS THAT HAVE BEEN ASSOCIATED WITH ERRORS. REFERENCE TO THE ACCELERATOR APS OPERATIONS MANUAL FOR TROUBLESHOOTING ASSISTANCE SHOULD REVIEWED SHOULD THESE ERRORS OCCUR. ADDITIONALLY, NO ADVERSE TRENDS WERE IDENTIFIED WITH THIS COMPLAINT ISSUE. BASED ON THE AVAILABLE INFORMATION, THE INVESTIGATION TEAM DID NOT IDENTIFY ANY SYSTEM ISSUES REQUIRING FURTHER ACTION. THE COMPLAINT IS AGAINST THE SYSTEM THAT IS FUNCTIONAL AT THE CUSTOMER SITE AND IS NOT AVAILABLE FOR RETURN. A RETURN WAS NOT NECESSARY TO EVALUATE THE ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. AN INVESTIGATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE ACCOUNT STATED SAMPLE BARCODE ID# (B)(4) WAS READ AND RELEASED WITHOUT BEING ASPIRATED ON THE APS SYSTEM. THE NEXT SAMPLE, ID# (B)(4), WAS ASPIRATED BUT THE RESULTS ASSIGNED TO SAMPLE ID# (B)(4). NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS 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 ARCHITECT I2000SR LN 3M74-01 SN (B)(4)| ARCHITECT I2000SR LN 3M74-01 SN (B)(4)