BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 2114140 · Received June 6, 2011

    Report

    Report Number
    1628664-2011-00264
    Event Type
    Malfunction
    Date Received
    June 6, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION WAS PERFORMED BY REVIEWING THE COMPLAINT TEXT, INSTRUMENT SERVICE HISTORY, AND OTHER CUSTOMER COMPLAINTS FOR SIMILAR ISSUES. THE PRESENT CUSTOMER ISSUE WAS RESOLVED BY ABBOTT FIELD SERVICE REPAIRING THE MICROPARTICLE DISPERSION GEAR AND, AS A PRECAUTION, REPLACING THE OUTER REAGENT CAROUSEL. A REVIEW OF OTHER CUSTOMER COMPLAINTS FOR SIMILAR ISSUES FOUND NO OTHER COMPLAINTS FOR CONTROL OR RESULT ISSUES DUE TO A FAILURE OF THE MICROPARTICLE DISPERSION GEAR. THE ARCHITECT SYSTEM OPERATIONS MANUAL (201837-108), JANUARY 2010 AND THE ARCHITECT STAT TROPONIN-I REAGENT PACKAGE INSERT (840653/R08), MARCH 2010 CONTAIN INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. BASED UPON THE DATA AVAILABLE AND THE RESULTS OF THIS EVALUATION NO PRODUCT DEFICIENCY WAS IDENTIFIED. REVIEW OF COMPLAINT TRACKING AND TRENDING; FIELD SERVICE INTERVENTION. OUTER REAGENT CAROUSEL.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A FALSE NEGATIVE RESULT WAS GENERATED FOR ONE PATIENT SAMPLE TESTED WITH THE ARCHITECT STAT TROPONIN ASSAY. THE CUSTOMER STATES THAT DURING THE MORNING START-UP OF THE ARCHITECT I2000SR ANALYZER, THE LOW CONTROL FOR THE STAT TROPONIN-I ASSAY GENERATED A RESULT OF 0.00 UG/L WHEN THE EXPECTED RESULT WAS 0.04 UG/L. THE CUSTOMER STOPPED USING THE ANALYZER TO TROUBLESHOOT THE LOW CONTROL RESULT. THE CUSTOMER PERFORMED SOME TROUBLESHOOTING AND MOVED THE ANALYZER FROM THE READY TO RUNNING MODE OF OPERATION. DURING THIS TIME, THE REAGENT BOTTLE BARCODE READ FOR THE STAT TROPONIN-I MICROPARTICLES BOTTLE FAILED. AN ABBOTT FIELD SERVICE ENGINEER (FSE) WAS ON SITE AT THIS TIME AND FOUND THAT A DISPERSION CAROUSEL POSITION GEAR HAD FALLEN OFF. THE FSE RESOLVED THE ISSUE. THE LAB MANAGER THEN DECIDED TO REPEAT ALL TROPONIN-I SAMPLES RUN AFTER THE LAST CONTROL RUN THAT HAD PASSED (TROPONIN-I CONTROLS ARE RUN APPROXIMATELY FOUR TIME PER DAY). THE LAB ALSO NOTIFIED ALL HOSPITAL DEPARTMENTS THAT ALL SAMPLES FROM THIS TIME PERIOD (APPROXIMATELY FOUR HOURS) WERE BEING RETESTED. THE RETESTING FOUND THAT 13 DISCREPANT SETS OF ARCHITECT STAT TROPONIN-I ASSAY RESULTS WERE GENERATED. NO OTHER ASSAY WAS AFFECTED. THE CUSTOMER WOULD ONLY PROVIDE THE FOLLOWING RESULTS (THE HOSPITAL USES A TROPONIN-I CUT-OFF VALUE OF 0.03 UG/L): SAMPLE ID: (B)(6) (FEMALE), INITIAL RESULT: 0.000, REPEAT RESULT: 0.048 UG/L. ALL CONTROLS PASSED AT THIS POINT. THE REPEAT RESULTS WERE SIMILAR TO THE RESULTS GENERATED FOR THIS PATIENT UPON HOSPITAL ADMISSION. THE PATIENT WAS INITIALLY ADMITTED FOR MONITORING BECAUSE OF ELEVATED ARCHITECT STAT TROPONIN-I ASSAY RESULTS. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH STAT TROPONIN-I LN: 2K41| ARCH STAT TROPONIN-I LN: 2K41