BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 2220891 · Received August 23, 2011

    Report

    Report Number
    1628664-2011-00583
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. NO CONSEQUENCES OR IMPACT TO PATIENT (B)(4). INCORRECT OR INADEQUATE RESULT (B)(4).

    Additional Manufacturer Narrative · 1

    A SAMPLE MISMATCH OCCURRED ON THE ARCHITECT I2000SR ANALYZER ATTACHED TO AN ACCELERATOR APS. THE I2000SR RECEIVED TWO CONSECUTIVE SAMPLE IN POSITION MESSAGES WITHOUT RECEIVING A SAMPLING COMPLETE MESSAGE AFTER THE FIRST SAMPLE. THE I2000SR PROPERLY GENERATED ERROR CODE 8275, SAMPLE PRESENTATION ERROR, BUT THE CUSTOMER CLAIMS THE APS DID NOT PROPERLY MANAGE THE ERROR AND SENT THE INFORMATION TO THE MIDDLEWARE. REVIEW OF SYSTEM LOGS INDICATED THAT THE APS SENT ERROR MESSAGE U09 (SAMPLING ERROR) TO THE MIDDLEWARE INSTEAD OF ERROR X01 (SAMPLE PRESENTATION). BY DESIGN, THE APS SENDS THE U09 MESSAGE TO THE MIDDLEWARE WHEN A SAMPLING ERROR IS REPORTED TO THE APS BY THE ARCHITECT. THE APS ONLY GENERATES AN X01 MESSAGE WHEN THE APS IDENTIFIES A SAMPLE PRESENTATION ERROR. IN THIS CASE, THE ARCHITECT IDENTIFIED THE ERROR, THEREFORE, THE ERROR MESSAGE WAS PROPERLY GENERATED. THERE IS NO ISSUE INVOLVING THE COMMUNICATION OF THE SAMPLE PRESENTATION ERROR. THE 8275 ERROR OCCURRED AFTER A RECENT UPGRADE TO THE APS SYSTEM SOFTWARE. INPECO DETERMINED THAT THE SYSTEM IS NOT FUNCTIONING AS INTENDED. ROOT CAUSE IS NOT KNOWN AT THIS TIME. THE ARCHITECT SYSTEM OPERATIONS MANUAL, 201837-108 CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED OTHER COMPLAINTS FOR THE OCCURRENCE OF ERROR CODE 8275 ON AN ARCHITECT I2000SR ANALYZER ATTACHED TO AN APS. CORRECTIVE ACTION FOR ERROR CODE 8275 IN THE ARCHITECT SYSTEM OPERATIONS MANUAL DIRECTS THE OPERATOR, "DO NOT REPORT RESULTS FOR EITHER SID. REFER TO YOUR LAS (LABORATORY AUTOMATION SYSTEM) DOCUMENTATION FOR TROUBLESHOOTING SAMPLE PRESENTATION ERRORS."

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A SAMPLE IDENTIFICATION ERROR OCCURRED FOR ONE SAMPLE TESTED ON THE ARCHITECT I2000SR ANALYZER, WHICH IS CONNECTED TO AN ACCELERATOR APS (AUTOMATED PROCESSING SYSTEMS) IOM (INPUT/OUTPUT MODULE). RESULTS FOR SAMPLE (B)(4) WERE GENERATED FROM THE SERUM OF SAMPLE (B)(4). THE CUSTOMER STATES THAT THE ARCHITECT ANALYZER CORRECTLY GENERATED ERROR CODE 8275 (SAMPLE PRESENTATION ERROR) FOR THIS ISSUE. THIS INFORMATION WAS TRANSMITTED TO THE APS AND THEN ONTO THE LABORATORY'S INFORMATION SYSTEM WITH THE MISMATCHED RESULTS. THE CUSTOMER DID NOT REPORT THE INCORRECT RESULTS FROM THE LAB BECAUSE THE PATIENT'S CLINICAL HISTORY DID NOT CORRELATE TO THE RESULTS. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    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 APS I/O MOD LN: 07L01-01 SN: (B)(4)| APS I/O MOD LN: 07L01-01 SN: (B)(4)