BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROPONIN T

    MDR report key: 2935612 · Received January 30, 2013

    Report

    Report Number
    1823260-2013-00536
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 12, 2013
    Report Date
    September 9, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961500
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE BASED ON THE PROVIDED INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER DISCOVERED QUESTIONABLE TROPONIN T RESULTS HAD BEEN GENERATED BY THE ANALYTICAL E MODULE SERIAL NUMBER (B)(4) WHEN THEY NOTED THE QC RESULTS WERE HALF OF THE NORMAL RESULT. ALL PATIENT SAMPLES TESTED SINCE THE LAST VALID QC WERE REPEATED ON THE ELECSYS 2010 ANALYZER SERIAL NUMBER (B)(4) ON (B)(6) 2013. OF THE DATA PROVIDED FOR 52 PATIENT SAMPLES, THE RESULTS FOR 11 PATIENT SAMPLES WERE DISCREPANT. ALL RESULTS ARE IN NG/ML. PATIENT SAMPLE 1 INITIAL RESULT WAS 0.019 AND THE REPEAT RESULT WAS 0.042. PATIENT SAMPLE 2 INITIAL RESULT WAS 0.156 AND THE REPEAT RESULT WAS 0.225. PATIENT SAMPLE 3 INITIAL RESULT WAS 4.88 AND THE REPEAT RESULT WAS 6.86. THE FOLLOWING SAMPLES WERE ORIGINALLY TESTED (B)(6) 2013. PATIENT SAMPLE 4 INITIAL RESULT WAS 0.075 AND THE REPEAT RESULT WAS 0.112. PATIENT SAMPLE 5 INITIAL RESULT WAS 6.79 AND THE REPEAT RESULT WAS 9.44. PATIENT SAMPLE 6 INITIAL RESULT WAS 1.04 AND THE REPEAT RESULT WAS 1.49. PATIENT SAMPLE 7 INITIAL RESULT WAS 0.014 AND THE REPEAT RESULT WAS 0.03. THE DATE OF ORIGINAL TESTING WAS UNKNOWN FOR THE FOLLOWING SAMPLES. PATIENT SAMPLE 8 INITIAL RESULT WAS <0.010 AND THE REPEAT RESULT WAS 0.023. PATIENT SAMPLE 9 INITIAL RESULT WAS 0.013 AND THE REPEAT RESULT WAS 0.033. PATIENT SAMPLE 10 INITIAL RESULT WAS 0.023 AND THE REPEAT RESULT WAS 0.046. PATIENT SAMPLE 11 INITIAL RESULT WAS 0.061 AND THE REPEAT RESULT WAS 0.102. THE INITIAL RESULTS HAD BEEN REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE CUSTOMER WAS NOT AWARE OF ANY ADVERSE EVENTS. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A BAD REAGENT PACK. HE CHECKED THE ANALYZER AND FOUND IT WAS FINE. THE CUSTOMER OPENED A NEW REAGENT PACK, CALIBRATED THE TROPONIN ASSAY AND RAN CONTROLS WHICH WERE FINE AND IN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40985 TROPONIN T IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS NA 16887801

    Patients

    Seq Age Sex Outcome Treatment
    1