BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT I1000SR ANALYZER

    MDR report key: 1963010 · Received January 18, 2011

    Report

    Report Number
    1628664-2011-00050
    Event Type
    Injury
    Date Received
    January 18, 2011
    Report Date
    January 6, 2011
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    MMI
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ABBOTT FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND PERFORMED THE FOLLOWING INSTRUMENT CHECKS: INSPECTION OF ALL HYDRAULIC CONNECTIONS ON THE PUMPS, SYRINGES, VALVES, MANIFOLDS, HEATERS, AND SOLUTION BOTTLES; PIPETTING ARM, TRIGGER, AND PRE-TRIGGER ASPIRATION AND DISPENSING PRECISIONS; AND BACKGROUND READINGS OF THE OPTICAL SYSTEM. ALL CHECKS MET SPECIFICATIONS. THE FSE THEN RETESTED PATIENT SAMPLES FROM THAT DAY AND ALL SHOWED NO VARIATIONS IN MEDICAL RELEVANCE. TO VERIFY THE RESULTS GENERATED FROM THIS I1000SR ANALYZER, THE CUSTOMER RAN 10 SAMPLES ON AN ARCHITECT I2000 ANALYZER AND ANOTHER ARCHITECT I1000SR ANALYZER. SAMPLE RESULTS WERE AT THE LOW END OF THE RANGE (0.000 TO 1.000 NG/ML). ALL SAMPLES CORRELATED AND HAD PEARSON CORRELATION COEFFICIENTS OF 0.970 OR HIGHER. SEVERAL LOW AND MEDIUM CONTROL POINTS WERE PLOTTED ON A CONTROL CHART, AND ALL CONTROL POINTS WERE WITHIN SPECIFICATION WITH ACCEPTABLE PRECISION. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT STAT TROPONIN-I REAGENT PACKAGE INSERT (840653/R08) AND THE ARCHITECT SYSTEM OPERATIONS MANUAL (201837), JANUARY 2010, BOTH CONTAIN INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. BASED UPON THE DATA AVAILABLE AND THE RESULTS OF THIS CURRENT EVALUATION, A DEFINITIVE CAUSE FOR THIS CUSTOMER'S ISSUE COULD NOT BE ESTABLISHED. A PRODUCT MALFUNCTION WAS NOT IDENTIFIED. ADDITIONAL INFORMATION: PATIENT'S ARCHITECT STAT TROPONIN-I RESULTS WERE 0.039 AND 0.031 NG/ML. THE CUSTOMER USES A MYOCARDIAL INFARCTION CUT-OFF FOR THIS ASSAY OF 0.03 NG/ML. METHOD: REVIEW OF COMPLAINT TRACKING AND TRENDING; FIELD SERVICE INTERVENTION.

    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 FALSELY ELEVATED ARCHITECT STAT TROPONIN-I ASSAY RESULT WAS GENERATED ON THE ARCHITECT I1000SR ANALYZER THAT RESULTED IN A CARDIAC CATHETERIZATION BEING PERFORMED THAT WAS DEEMED UNNECESSARY BY THE PATIENT'S PHYSICIAN. NO TEST VALUES WERE PROVIDED BY THE CUSTOMER. THERE IS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I1000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER MMI ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability ARCH STAT TN-I LN: 2K41-28 LOT: 42894UN10| ARCH STAT TN-I LN: 2K41-28 LOT: 42894UN10