BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 3090566 · Received May 2, 2013

    Report

    Report Number
    1628664-2013-00111
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 12, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    LGD
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED TROUBLESHOOTING THE INSTRUMENT, A LABELING REVIEW, HISTORICAL/QUALITY DATA REVIEW AND SERVICE HISTORY REVIEW. TROUBLESHOOTING WAS PERFORMED AND THE SYRINGE VALVE, PROBE, AND PRESSURE SENSOR WERE REPLACED. THE PRESSURE SENSOR PART NO. 7-204070-01 IS DOCUMENTED AS THE PROBABLE LIKELY CAUSE OF THE DISCREPANT RESULTS. A PRODUCT LABELING REVIEW FOUND THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE TOXO IGG AND (B)(6) QUALITATIVE II ASSAY PACKAGE INSERTS CONTAIN ADEQUATE INFORMATION FOR THE DESCRIBED ISSUE. A HISTORICAL/QUALITY DATA REVIEW OF 12 MONTHS OF INFORMATION DID NOT IDENTIFY ANY ADVERSE TREND OF PRESSURE SENSOR ISSUES CAUSING DISCREPANT RESULTS. A SERVICE HISTORY REVIEW FOUND NO SERVICE HISTORY ISSUES WITH I2000SR SERIAL NO. (B)(4). NO ADDITIONAL DISCREPANT RESULT COMPLAINTS, OR COMPLAINTS FOR PRESSURE SENSOR ISSUES WERE FOUND TO HAVE BEEN DOCUMENTED FOR I2000SR SERIAL NO. (B)(4) SINCE TROUBLESHOOTING WAS PERFORMED AND THE PRESSURE SENSOR WAS REPLACED. THE COMPLAINT INVESTIGATION INFORMATION DID NOT REASONABLY SUGGEST A DEVICE MALFUNCTION CAUSED THIS ISSUE. THE DISCREPANT RESULT ISSUE WAS RESOLVED THOUGH TROUBLESHOOTING AND THE REPLACEMENT OF A USED PRESSURE SENSOR. NO SYSTEMIC DEFICIENCY OR ADVERSE TREND OF A PRESSURE SENSORS ISSUE CAUSING DISCREPANT RESULTS WAS IDENTIFIED DURING THIS INVESTIGATION. BASED ON THE RESULTS OF THIS EVALUATION, NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSE REACTIVE TOXOPLASMOSIS IGG RESULT FOR ONE PATIENT ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED FROM (B)(6) 2013 SID (B)(4) INITIAL: 188 IU/ML, REPEAT NONREACTIVE (CONCENTRATIONS OF GREATER THAN OR EQUAL TO 3.0 IU/ML ARE CONSIDERED REACTIVE). TOXOPLASMOSIS IGM RESULT WAS NONREACTIVE. THE PATIENT HAD A HISTORY OF BEING TOXO IGG NONREACTIVE. AN ERROR CODE OF 3350 (R1 PROBE) WAS OBTAINED WHILE RUNNING A DIFFERENT ASSAY. OCCASIONALLY THE PRESSURE CONTROL VALUES DROPPED ON THE SAMPLE PIPETTOR, HOWEVER, NO ANOMALY WITH R1 OR R2 WAS FOUND. THE CUSTOMER REPLACED THE NEEDLE, PRESSURE SENSOR AND SYRINGE VALVE ON THE ARCHITECT INSTRUMENT AS A PREVENTIVE MEASURE. THE SAMPLE AND STAT PIPETTOR PRESSURE CARDS WERE SWITCHED OUT. OTHER ACTIONS TAKEN: CALIBRATION AND SAMPLE PIPETTOR PRESSURE TEST, FLUIDICS CHECKED AND MULTI CONTROL LEVEL 2 RUN. FOLLOWING THAT THE INSTRUMENT IS WORKING ACCORDING TO THE EXPECTED SPECIFICATIONS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192996 ARCHITECT I2000SR ANALYZER LGD ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 LN 06C19-25 LOT UNKNOWN| ARCHITECT TOXOPLASMOSIS IGG| ARCHITECT TOXOPLASMOSIS IGG| LN 06C19-25 LOT UNKNOWN