BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 1884318 · Received October 27, 2010

    Report

    Report Number
    1415939-2010-00527
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    October 17, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN PLACE OF PERFORMING ACCURACY TESTING WITHIN THIS CURRENT COMPLAINT EVALUATION, A REVIEW WAS PERFORMED OF HISTORICAL DATA FROM A PREVIOUS EVALUATION THAT USED THE SAME LOT NUMBER OF REAGENT (B)(4). THE ACCEPTANCE CRITERIA FOR CONTROLS, CALIBRATORS AND TROPONIN-I PANEL 1 SAMPLES WERE MET WITH ALL RESULTS WITHIN SPECIFICATIONS. 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 ASSAY PACKAGE INSERT (B)(4) CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. BASED ON THE CURRENT EVALUATION, A PRODUCT MALFUNCTION WAS NOT IDENTIFIED. NO NEW OR ADDITIONAL ISSUES WERE IDENTIFIED REQUIRING FURTHER INVESTIGATION. EVALUATION, METHOD: REVIEW OF COMPLAINT TRACKING AND TRENDING.

    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 SERUM AND A PLASMA SAMPLE WERE DRAWN FROM ONE PATIENT AND TESTED WITH THE ARCHITECT STAT TROPONIN-I ASSAY ON AN ARCHITECT (B)(4) ANALYZER ((B)(4)). THE SERUM SAMPLE GENERATED THE FOLLOWING RESULT: 9.8 NG/L. THE PLASMA SAMPLE GENERATED THE FOLLOWING RESULTS: 40.7, 24.0, AND 13.5 NG/L. THE CUSTOMER USES A CUT-OFF VALUE OF 30 NG/L. BOTH SAMPLES WERE THEN FROZEN. THREE DAYS LATER, BOTH SAMPLES WERE THAWED AND CENTRIFUGED AND RETESTED ON A DIFFERENT ARCHITECT (B)(4) ANALYZER ((B)(4)). THE SERUM RESULTS RANGED FROM 7.2 TO 58.0 NG/L AND THE PLASMA SAMPLE GENERATED RESULTS RANGING FROM 14.8 TO 28.2 NG/L. THERE IS NO IMPACT TO PATIENT MANAGEMENT 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 37043UN10

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000 LN:3M74-01 SNS: (B)(4)| ARCH I2000 LN:3M74-01 SNS: (B)(4)