BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 2924136 · Received January 22, 2013

    Report

    Report Number
    1415939-2013-00017
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 29, 2012
    Report Date
    January 14, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(6).

    Additional Manufacturer Narrative · 1

    CORRECT LIST NUMBER IS 02K41-28. A PRODUCT EVALUATION WAS PERFORMED IN ORDER TO INVESTIGATE FALSELY ELEVATED TROPONIN RESULTS. A REVIEW OF CUSTOMER COMPLAINTS RECEIVED TO-DATE DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITIY RELATED TO DISCREPANT PATIENT RESULTS WITH ARCHITECT STAT TROPONIN-I, LIST 2K41-28, LOT 17330UN12. ACCURACY TESTING WAS COMPLETED USING AN INTERNAL TROPONIN-I PANEL AND RETAINED KITS OF REAGENT LOT 17330UN12 WHICH MET ACCEPTANCE CRITERIA. THE CUSTOMER WAS REFERRED TO THE ARCHITECT STAT TROPONIN I REAGENT PACKAGE INSERT - LIMITATIONS OF THE PROCEDURE SECTION AND THE SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS SECTION FOR ADDITIONAL INFORMATION. BASED ON THE RESULTS OF THIS EVALUATION, THE ARCHITECT STAT TROPONIN-I ASSAY, LN 2K41-28, LOT 17330UN12, IS PERFORMING AS INTENDED AND NO PRODUCT DEFICIENCY OR MALFUNCTION WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE PATIENT SERUM SAMPLE GENERATED A FALSE POSITIVE ARCHITECT STAT TROPONIN-I ASSAY RESULT OF 0.2166NG/ML. THE CUSTOMER PERFORMED MULTIPLE RUNS ON THE SAMPLE WITH THE SAME REAGENT LOT, GENERATING THE FOLLOWING RESULTS:REPORTED RESULT (NG/ML) COMPLETION DATE 0.2166 (B)(6) 2012 0.0214 (B)(6) 2012 0.0212 (B)(6) 2012THE CUSTOMER USES A CUT-OFF VALUE OF 0.028 NG/ML. READ ERRORS OCCURRED SPORADICALLY DURING THE MULTIPLE DETERMINATIONS. LEVEL 1 TROPONIN CONTROL WAS WITHIN RANGE. INSTRUMENT CHECKS PASSED; HOWEVER, THE TRIGGER DISPENSE VALVE WAS NOT DISPENSING SO IT WAS REPLACED. A TEN-FOLD PRECISION DETERMINATION OF BHCG WAS PERFORMED, WHICH WAS ACCEPTABLE. THE CUSTOMER TECHNICAL ADVOCATE RECOMMENDED TO THE CUSTOMER TO SWITCH TO PLASMA SAMPLES AS THE CUSTOMER'S TIME BETWEEN SERUM SAMPLE DRAW AND CENTRIFUGATION DID NOT ALLOW FOR ADEQUATE CLOT FORMATION. THE CUSTOMER REPLACED THE PROBE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30314 ARCHITECT STAT TROPONIN-I MMI ABBOTT LABORATORIES 17330UN12

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR, LN 01L86-40, SN (B)(4)| ARC I1000SR: 01L86-40: SN: (B)(4)