BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 3941394 · Received July 17, 2014

    Report

    Report Number
    1415939-2014-00157
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    COMPLAINT ACTIVITY WAS REVIEWED AND IDENTIFIED NO ADVERSE TRENDS IN ASSOCIATION WITH THE ISSUE CURRENTLY UNDER EVALUATION. THE TREND REVIEW IDENTIFIED NORMAL COMPLAINT ACTIVITY FOR THE ISSUE UNDER INVESTIGATION. ACCURACY TESTING WAS PERFORMED USING A RETAINED KIT OF LOT 61948UN13 AGAINST A PANEL THAT USES THE SAME MATRIX AS PATIENT SAMPLES USED FOR TESTING DURING MANUFACTURING. ALL RESULTS MET THE SPECIFICATION OF 0.23 TO 0.43 NG/ML, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. THE ARCHITECT STAT TROPONIN-I ASSAY PACKAGE INSERT CONTAINS INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE AVAILABLE INFORMATION FROM THE CUSTOMER SITE AND FROM THE RESULTS OF THIS EVALUATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST A PRODUCT MALFUNCTION OCCURRED. THE ISSUE IS RELATED TO ONE DISCREET PATIENT SAMPLE. NO ADDITIONAL ISSUES WERE IDENTIFIED AND NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I ASSAY RESULT FOR ONE PATIENT SAMPLE GENERATED ON AN ARCHITECT I1000SR ANALYZER. AN ELEVATED RESULT OF 18 NG/ML WAS GENERATED WITH NO INDICATIONS OF A MYOCARDIAL INFACT UPON ELECTROCARDIOGRAM EXAMINATION (THE CUSTOMER USES A CUT-OFF OF GREATER THAN 0.3 NG/ML). NO SUSPECT RESULTS WERE REPORTED FROM THE LAB WITH NO PATIENT IMPACT. CONTROLS REMAINED WITHIN SPECIFICATION. THE SAMPLE WAS SENT TO A REFERENCE LAB THAT ALSO USES THE ARCHITECT PLATFORM AND RESULTS OF 18.22 AND 18.54 NG/ML WERE GENERATED. THE CKMB RESULTS FOR THIS SAMPLE WERE WITHIN NORMAL REFERENCE RANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418296 ARCHITECT STAT TROPONIN-I TROPONIN-I MMI ABBOTT LABORATORIES 61948UN13

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR ANALYZER LN: 01L86-01| ARCHITECT I1000SR ANALYZER LN: 01L86-01| SN: (B)(4)| SN: (B)(4)