BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 2221037 · Received August 23, 2011

    Report

    Report Number
    1628664-2011-00584
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION WAS PERFORMED AND INCLUDED A REVIEW OF THE INFORMATION PROVIDED BY THE CUSTOMER, THE CUSTOMER'S SYSTEM LOGS, COMPLAINT AND INTERNAL INFORMATION, AND THE ARCHITECT SYSTEM OPERATIONS MANUAL. THE EVALUATION DETERMINED THE SAMPLE SKIP AND ERROR 4200 WERE CAUSED BY THE BAR CODE (BC) TRANSITION VALUE BEING SET TOO LOW; AT THE DEFAULT VALUE OF 30. A REVIEW OF THE CUSTOMER'S SYSTEM LOGS VERIFIED THE ISSUE AND SHOWED MULTIPLE OCCURRENCES OF ERRORS 4200 AND 0518 ASSOCIATED WITH NON BC BATCH RUNS. ABBOTT FIELD SERVICE PERFORMED A PROCEDURE (SET BAR CODE TRANSITIONS) TO CHANGE THE TRANSITION VALUE TO 90 WHICH RESOLVED THE CUSTOMER'S ISSUE. THE BC TRANSITION VALUE IS CRITICAL TO THE DISCRIMINATION OF NB (NO BARCODE) AND NR (UNREADABLE BARCODE). IN THE CUSTOMER'S CASE, THE SKIPPED SAMPLE GENERATED NR INSTEAD OF NB BECAUSE THE BC READER TRANSITION VALUE WAS SET TOO LOW. A 12 MONTH REVIEW OF TRACKING AND TRENDING DID NOT REVEAL ANY NON-STATISTICAL OR ADVERSE TRENDS. THE ARCHITECT OPERATIONS MANUAL PROVIDES DETAILED INSTRUCTIONS FOR BATCH PROCESSING. WHEN RUNNING A NON-BAR CODED BATCH YOU CANNOT: LOAD CALIBRATORS, LOAD PRIORITY SAMPLES IN THE SSH, LEAVE EMPTY SPACES IN A CARRIER, AND/OR LOAD BATCH SAMPLES IN A CARRIER WITH TESTS IN PROCESS. THESE INSTRUCTIONS ARE RE-ENFORCED BY DISPLAYING MESSAGE 0518 (AVOID LOADING CALIBRATORS, QC, PRIORITY SAMPLES OR LEAVING EMPTY SPACES IN A CARRIER WHEN RUNNING A NON-BAR CODED BATCH) WHEN A NON BC RUN IS INITIATED. THE OPERATIONS MANUAL ALSO PROVIDES PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR ERRORS 4200 AND 0120. A DEFICIENCY WAS NOT IDENTIFIED. THE CUSTOMER'S BC TRANSITION VALUE WAS EDITED TO RESOLVE THE ISSUE. THE SOFTWARE IS PERFORMING PER REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    NO CONSEQUENCES OR IMPACT TO PATIENT. DEVICE OPERATES DIFFERENTLY THAN EXPECTED. POSITIONING ISSUE. DEVICE DISPLAYS ERROR MESSAGE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED WHILE RUNNING PATIENT SAMPLES ON THE ARCHITECT I2000 SR ANALYZER, HE NOTICED THAT THE INSTRUMENT SKIPPED A PATIENT TUBE AND THE SAMPLES BECAME OUT OF SEQUENCE. THE SAMPLES WERE RUN AS A NON-BARCODED BATCH. THE INSTRUMENT DID NOT PICK UP THE SAMPLE AT A CERTAIN POSITION ON THE TRAY, AND ERROR 4200 (UNABLE TO READ BAR CODE LABEL AT CARRIER (X) POSITION (Y)) WAS DISPLAYED. AT THIS POINT THE INSTRUMENT PICKED UP THE SUBSEQUENT SERUM SAMPLE AND TREATED IT LIKE THE ONE THAT WAS NOT PICKED UP, AND GAVE IT ITS SEQUENCE NUMBER AS WELL, SHIFTING EVERYTHING AHEAD BY ONE POSITION. THIS LED TO A ONE-POSITION DISCREPANCY BETWEEN SAMPLE AND SEQUENCE NUMBER. THE CUSTOMER DISCOVERED THE DISCREPANCY BECAUSE THE RESULTS DID NOT MATCH WITH PREVIOUS RESULTS GENERATED ON ANOTHER INSTRUMENT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000SR ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1