BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 1953380 · Received January 8, 2011

    Report

    Report Number
    1415939-2011-00015
    Event Type
    Malfunction
    Date Received
    January 8, 2011
    Date of Event
    December 5, 2010
    Report Date
    December 13, 2010
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). A STUDY WAS CONDUCTED USING NINE LEVELS OF HUMAN SERUM PANELS PREPARED TO CONCENTRATIONS RANGING FROM 0.01 NG/ML TO 0.20 NG/ML. PANELS WERE TESTED IN REPLICATES OF 2 TWICE EACH DAY FOR A PERIOD OF 5 DAYS ACROSS 2 INSTRUMENTS. USING AN IN-HOUSE FILE KIT OF REAGENT LOT 39483UN10, A TOTAL OF 20 REPLICATES PER PANEL PER INSTRUMENT WERE TESTED. THE %CV'S OF EACH PANEL WERE CALCULATED AND PLOTTED AGAINST THE MEAN CONCENTRATIONS OF EACH PANEL. A CURVE WAS THEN FITTED THROUGH THE DATA POINTS AND THE 10% CV VALUE WAS ESTIMATED AS THE CONCENTRATION CORRESPONDING TO THE 10% CV LEVEL OF THE FITTED CURVE. THE TEST RESULTS MET THE ASSAY'S PACKAGE INSERT CLAIM, THAT THE ARCHITECT STAT TROPONIN-I CONCENTRATION AT 10% CV IS LESS THAN OR EQUAL TO 0.10 NG/ML. IN ADDITION TO TESTING, COMPLAINTS WERE REVIEWED FROM (B)(4) 2010 THROUGH (B)(4) 2011 TO DETERMINE IF OTHERS HAVE EXPERIENCED SIMILAR ISSUES THAT MIGHT WARRANT FURTHER INVESTIGATION. THIS REVIEW DID NOT IDENTIFY AN ADVERSE TREND RELATED TO THE CUSTOMER'S OBSERVATION. BASED ON THE RESULTS OF THIS INVESTIGATION, A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER HAS OBSERVED IMPRECISION ISSUES WITH THE ARCHITECT STAT TROPONIN-I ASSAY ACROSS TWO I2000SR ANALYZERS WHERE THE ORIGINAL RESULT DOES NOT REPEAT. THE CUSTOMER HAS AN APS TRACK SYSTEM IN THEIR LABORATORY WITH TWO I2000SR ANALYZERS ATTACHED. AN ALGORITHM HAS BEEN SET UP IN THEIR INSTRUMENT MANAGER SOFTWARE AND RESULTS BETWEEN 0.03 AND 0.3 NG/ML ARE AUTOMATICALLY REPEATED. THE CUSTOMER PROVIDED PATIENT DATA GENERATED BETWEEN (B)(6) 2010. FOURTEEN PATIENT SAMPLES HAD DISCREPANT VALUES THAT CROSSED THE CUSTOMER'S CUT-OFF OF 0.03 NG/ML. THIS REPORT IS FOR PATIENT #14 OF 14 SIMILAR IMPRECISION REPORTS. THE INITIAL RESULT WAS 0.034 NG/ML AND UPON REPEAT, YIELDED RESULTS OF 0.025 AND 0.029 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT STAT TROPONIN-I FOR THE DETERMINATION OF CARDIAC TROPONIN-I IN HUMAN SERUM OR PLASMA MMI ABBOTT LABORATORIES 39483UN10

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR LIST # 3M74-01 SERIAL # (B)(4)| ARCHITECT I2000SR LIST # 3M74-01 SERIAL # (B)(4)