BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYVA EMIT TOX SERUM TRICYCLIC ANTIDEPRESSANTS ASSAY

    MDR report key: 6637583 · Received June 13, 2017

    Report

    Report Number
    2517506-2017-00532
    Event Type
    Malfunction
    Date Received
    June 13, 2017
    Date of Event
    May 20, 2017
    Report Date
    June 13, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    LFG
    PMA / PMN Number
    K821743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) HEADQUARTERS SUPPORT CENTER CONCLUDED THAT THE CAUSE OF THE DISCORDANT TRICYCLIC ANTIDEPRESSANT (TCA) RESULT ON THE URINE SURVEY SAMPLE WAS DUE TO THE OPERATOR RUNNING THE TCA AS USER DEFINED METHOD (UDM). BASED ON THE (B)(6) REPORT PROVIDED BY THE OPERATOR, THE USE OF METHODOLOGY EIA AND 1000 NG/ML CUTOFF FOR THIS SAMPLE WAS GRADED AS NON-CONSENSUS. THE SYVA EMIT TOX SERUM TRICYCLIC ANTIDEPRESSANT ASSAY WAS VALIDATED BY SIEMENS TO BE USED WITH HUMAN OR SERUM WITH A 300 NG/ML CUTOFF FOR SERUM. THE OPERATOR IS RUNNING THIS ASSAY WITH URINE PATIENT SAMPLES, URINE SURVEY SAMPLES, AND URINE CONTROLS WITH A 1000NG/ML CUTOFF, WHICH IS A SERUM CALIBRATOR. ACCORDING TO THE SYVA EMIT TOX SERUM TRICYCLIC ANTIDEPRESSANTS ASSAY'S INSTRUCTION FOR USE (IFU), "USER DEFINED MODIFICATIONS ARE NOT SUPPORTED BY SIEMENS AS THEY MAY AFFECT PERFORMANCE OF THE SYSTEM AND ASSAY RESULTS. IT IS THE RESPONSIBILITY OF THE USER TO VALIDATE MODIFICATIONS TO THESE INSTRUCTIONS OR USE OF THE REAGENTS ON ANALYZERS OTHER THAN THOSE INCLUDED IN SIEMENS APPLICATION SHEETS OR THESE INSTRUCTIONS FOR USE". THE USER DID NOT FOLLOW PRODUCT INSTRUCTIONS IN THE INSTRUCTION FOR USE, RESULTING IN THE CAP FAILURE AND POTENTIAL HARM TO THE USER OR POTENTIAL ERRONEOUS PATIENT RESULTS. THE INSTRUMENT AND THE REAGENTS USED ARE PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE OR REAGENT IS REQUIRED.

    Description of Event or Problem · 1

    AN OPERATOR FAILED THE (B)(6) SURVEY WITH USER DEFINED METHOD (UDM) TRICYCLIC ANTI-DEPRESSANTS (TCA) ON MARCH 21, 2017. THE OPERATOR REPORTED THAT THEY SELECTED THE METHODOLOGY AS EIA 1000 FOR CUTOFF FOR TRICYCLIC GROUP. THE URINE SURVEY SAMPLE WAS SPIKED WITH 2000 NG/ML OF DOXEPIN AND BASED ON THE SYVA EMIT TOX SERUM TRICYCLIC ANTIDEPRESSANTS ASSAY'S INSTRUCTION FOR USE (IFU), A CONCENTRATION OF 500 NG/ML OF DOXEPIN SHOULD SHOW A POSITIVE RESPONSE AT THE 300 NG/ML CUTOFF IN SERUM OR PLASMA SAMPLE. THE OPERATOR OBTAINED AND REPORTED A DISCORDANT NEGATIVE RESULT ON THIS SAMPLE FOR TRICYCLIC GROUP. AFTER OBTAINING THE FAILURE REPORT, THE OPERATOR RE-RAN CALIBRATION AND CONTROLS AND CLAIMED THAT THE CALIBRATION AND CONTROLS RECOVERED WITHIN ACCEPTABLE RANGES. THE OPERATOR REMOVED THE SAME URINE SURVEY SAMPLE FROM THE REFRIGERATOR AND RE-RAN THE SURVEY SAMPLE. THE OPERATOR OBTAINED A NEGATIVE RESULT AGAIN. THE OPERATOR IS RUNNING THIS TCA ASSAY WITH URINE SAMPLES, URINE SURVEY SAMPLES AND URINE CONTROLS WITH A 1000NG/ML CUTOFF, WHICH IS A SERUM CALIBRATOR. THE OPERATOR CLAIMS THAT HE HAS BEEN REPORTING PATIENT TCA RESULTS TO PHYSICIAN AND THEY HAVE NOT QUESTIONED THE RESULTS. THIS SURVEY FAILURE DID NOT CAUSE A DELAY. THE LABORATORY CONTINUED TO RUN PATIENT SAMPLES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES. THE OPERATOR HAS INDICATED THAT THE ISSUE IS ONLY RELATED TO DISCORDANT CAP SURVEY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419883 SYVA EMIT TOX SERUM TRICYCLIC ANTIDEPRESSANTS ASSAY SYVA EMIT TOX SERUM TRICYCLIC ANTIDEPRESSANTS ASSAY LFG SIEMENS HEALTHCARE DIAGNOSTICS INC SYVA EMIT TOX SERUM TRICYCLIC ANTIDEPRESSANTS ASSAY K1

    Patients

    Seq Age Sex Outcome Treatment
    1