BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 3061966 · Received April 16, 2013

    Report

    Report Number
    1628664-2013-00098
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    MMI
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    AFTER THE INITIAL RESULT OF 0.245 NG/ML WAS GENERATED, FOLLOWED BY ERROR CODE 5503 ON THE DISPENSING PUMP IN WASH ZONE 2, FIELD SERVICE REPLACED THE 50 UL BUFFER PUMP (WASH ZONE 2). THE SAME SAMPLE WAS RETESTED WITH A RESULT OF 0.016 NG/ML AND THE ISSUE WAS CONSIDERED RESOLVED. A PRODUCT LABELING REVIEW FOUND THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE STAT-TROPONIN-I REAGENT PACKAGE INSERT CONTAIN ADEQUATE INFORMATION FOR TROUBLESHOOTING THE OBSERVED ISSUE. A SERVICE HISTORY REVIEW FOUND NO SERVICE HISTORY ISSUES WITH I2000SR SERIAL NO. (B)(4). NO ADDITIONAL DISCREPANT RESULT COMPLAINTS OR COMPLAINTS FOR 50 UL BUFFER PUMP (WASH ZONE) ISSUES WERE FOUND TO HAVE BEEN DOCUMENTED FOR I2000SR SERIAL NO. (B)(4) SINCE TROUBLESHOOTING WAS PERFORMED AND THE 50 UL BUFFER PUMP (WASH ZONE) WAS REPLACED. THE COMPLAINT INVESTIGATION INFORMATION REASONABLY SUGGESTS A DEVICE MALFUNCTION CAUSED THIS ISSUE. NO SYSTEMIC DEFICIENCY OR ADVERSE TREND OF A 50UL BUFFER PUMP (WASH ZONE 2) ISSUE CAUSING DISCREPANT RESULTS WAS IDENTIFIED DURING THIS INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A FALSE POSITIVE RESULT WAS GENERATED ON THE ARCHITECT STAT TROPONIN-I ASSAY. A PATIENT GENERATED AN INITIAL RESULT OF 0.245 NG/ML. WHEN THE SAME SAMPLE WAS RETESTED LATER THAT DAY, THE RESULT WAS 0.016 NG/ML. THE CUSTOMER USES A CUT-OFF OF 0.030 NG/ML. THE INSTRUMENT GENERATED ERROR CODE 5503 (STEP LOSS DETECTED) ON THE DISPENSING PUMP IN WASH ZONE 2 WITH SUBSEQUENT INSTRUMENT SHUT-DOWN APPROXIMATELY 15 MINUTES AFTER THE SAMPLE WAS INITIALLY TESTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162393 ARCHITECT I2000SR ANALYZER MMI ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT # 56731UN12| LOT # 56731UN12| ARCHITECT STAT TROPONIN-I LIST # 2K41-38| ARCHITECT STAT TROPONIN-I LIST # 2K41-38