BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 3173407 · Received June 17, 2013

    Report

    Report Number
    1415939-2013-00266
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 4, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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).

    Additional Manufacturer Narrative · 1

    AN ACCURACY STUDY WAS PERFORMED TO EVALUATE ASSAY PERFORMANCE. AN INTERNAL TROPONIN-I PANEL WAS TESTED WITH REAGENT LOT 08594UN13 (ALL OF THE MATERIALS UTILIZED IN TESTING WERE STORED IN-HOUSE). THE TROPONIN-I PANEL IS TARGETED TO A KNOWN CONCENTRATION. THE PANEL RESULT WAS WITHIN SPECIFICATION, WHICH DEMONSTRATES THAT THE ASSAY CAN ACCURATELY DETECT A KNOWN CONCENTRATION OF TROPONIN-I. THE COMPLAINT TEXT INDICATES THAT THE INSTRUMENT GAVE MULTIPLE ASPIRATION ERRORS FOR THE SAMPLE PRIOR TO OBTAINING RESULTS. REPEAT OF THE SAMPLE PRODUCED ACCEPTABLE RESULTS WHICH INDICATES A SAMPLE SPECIFIC ISSUE. NO ADDITIONAL ISSUES WERE IDENTIFIED. 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 CONTAINS INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. RESULTS FROM THE PRODUCT EVALUATION DEMONSTRATE THAT THE ARCHITECT STAT TROPONIN-I ASSAY IS PERFORMING ACCEPTABLY. A PRODUCT MALFUNCTION WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS A FALSE POSITIVE ARCHITECT STAT TROPONIN-I ASSAY RESULT ON ONE PATIENT. AN INITIAL POSITIVE RESULT OF 2.931 NG/ML WAS GENERATED (ARCHITECT I2000SR ANALYZER SERIAL NUMBER (B)(4)) AND REPORTED FROM THE LAB. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND ADMINISTERED ASPIRIN AS A PRECAUTION. A NEW SAMPLE WAS TAKEN APPROXIMATELY 12 HOURS LATER AND GENERATED A NEGATIVE RESULT OF 0.033 NG/ML (ARCHITECT I2000SR ANALYZER SERIAL NUMBER (B)(4)). THE CLINICAL STAFF QUESTIONED THE INITIAL POSITIVE RESULT. THE INITIAL SAMPLE WAS RETESTED AND GENERATED A NEGATIVE RESULT OF 0.012 NG/ML (ARCHITECT I4000 ANALYZER). THE CUSTOMER USES THE FOLLOWING VALUES AS CUT-OFF POINTS FOR THIS ASSAY: NEGATIVE = LESS THAN 0.04 NG/ML; GRAYZONE = 0.04 TO 0.08 NG/ML; AND, POSITIVE = GREATER THAN OR EQUAL TO 0.08 NG/ML. THERE WAS NO FURTHER IMPACT TO THE PATIENT AS A RESULT OF THIS ISSUE. IT WAS NOTED THAT THE ARCHITECT I2000SR ANALYZER HAD EXPERIENCED NUMEROUS ASPIRATION ERRORS DURING THIS TIME AND THE CUSTOMER WAS HAVING QUALITY CONTROL ISSUES, ESPECIALLY WITH THE LOW LEVEL CONTROL. SAMPLE INTEGRITY ISSUES WERE ALSO DISCUSSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273235 ARCHITECT STAT TROPONIN-I MMI ABBOTT LABORATORIES 08594UN13

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ARCHITECT I2000SR LN: 03M74-01, SN: (B)(4)