BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1401911 · Received June 16, 2009

    Report

    Report Number
    1628664-2009-00221
    Event Type
    Malfunction
    Date Received
    June 16, 2009
    Date of Event
    May 20, 2009
    Report Date
    May 22, 2009
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS, NO RESULTS OR CONCLUSION CODE CAN BE CHOSEN AT THIS TIME. THIS IS AN INITIAL REPORT. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT TO UPDATE, BRAND NAME TO ARCHITECT I2000SR ANALYZER AND 510K TO K983212. THIS IS AN FOLLOW-UP REPORT TO CORRECT INFORMATION. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVALUATION OF THE ISSUE CONSISTED OF A REVIEW OF CUSTOMER COMPLAINTS, CURRENT ARCHITECT I2000SR LABELING, AND THE INFORMATION PROVIDED INCLUDING THE COMPLAINT TEXT. THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES MULTIPLE PROBABLE CAUSES AND CORRECTIVE ACTIONS TO ASSIST THE CUSTOMER WITH RESOLVING DISCREPANT RESULTS. THE PROBABLE CAUSES FOR DISCREPANT RESULTS INCLUDE TRIGGER SENSOR IS CRACKED AND TRIGGER DISPENSE IS INADEQUATE. THE COMPLAINT INFORMATION NOTES THE FIELD SERVICE REPRESENTATIVE (FSR) REPLACED THE CRACKED TRIGGER LEVEL SENSOR TO RESOLVE THE DISCREPANT TROPONIN PATIENT RESULT ISSUE. A COMPLAINT REVIEW FOUND THERE HAVE BEEN NO ADDITIONAL INCIDENTS OF DISCREPANT RESULT GENERATION BY ARCHITECT I2000SR (B)(4), SINCE THE DAMAGED TRIGGER LEVEL SENSOR WAS REPLACED. PLEASE REFER TO THE ARCHITECT SYSTEM OPERATIONS MANUAL TROUBLESHOOTING AND DIAGNOSTICS SECTION TO ASSIST WITH TROUBLESHOOTING ANY ISSUES WITH THE DISCREPANT RESULTS GENERATION. BASED ON THE AVAILABLE INFORMATION AND THIS INVESTIGATION, NO DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT I2000SR ANALYZER, LIST NUMBER 03M74-01. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A FALSE POSITIVE ARCHITECT TROPONIN-I RESULT ON A PATIENT WHO REPEATED NEGATIVE. IN 2009, THE PATIENT TESTED ARCHITECT TROPONIN-I POSITIVE (0.031). NO UNITS OF MEASUREMENT WERE PROVIDED FOR THE ARCHITECT TROPONIN-I VALUES. THE LABORATORY USES A CUTOFF OF 0.030 FOR ARCHITECT TROPONIN-I ASSAY. THE SPECIMEN WAS REPEATED WITH A NEGATIVE ARCHITECT TROPONIN-I RESULT (0.007). THE NEXT DAY, THE PATIENT AGAIN TESTED ARCHITECT TROPONIN-I NEGATIVE (0.017, 0.014). SERVICE CLEANED A SMALL AMOUNT OF BUFFER OFF THE WZ MANIFOLDS, CLEANED LARGE BUILD-UP OF DRIED DEBRIS ON ALL THE WASH CUPS AND REPLACED A STRAW THAT WAS CRACKED AT THE LID ON THE ARCHITECT ANALYZER. THE FALSE POSITIVE ARCHITECT TROPONIN-I RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS 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 ARCHITECT TROPONIN-I, LIST 2K41-20, LOT UNKNOWN| ARCHITECT TROPONIN-I, LIST 2K41-20, LOT UNKNOWN| ARCHITECT TROPONIN-I, LIST 2K41-20, LOT UNKNOWN