MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC SYVA EMIT TOX SERUM TRICYCLIC ANTIDEPRESSANTS ASSAY

Model Number	SYVA EMIT TOX SERUM TRICYCLIC ANTIDEPRESSANTS ASSAY
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: SYVA EMIT TOX SERUM TRICYCLIC ANTIDEPRESSANTS ASSAY
• Common Device Name: SYVA EMIT TOX SERUM TRICYCLIC ANTIDEPRESSANTS ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 6637583
• Report Number: 2517506-2017-00532
• Device Sequence Number: 80193
• Product Code: LFG
• Combination Product (Y/N): N
• PMA/510(K) Number: K821743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Type of Report: Initial
• Report Date (Section B): 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2019
• Device Model Number: SYVA EMIT TOX SERUM TRICYCLIC ANTIDEPRESSANTS ASSAY
• Device Catalogue Number: 10445389
• Device Lot Number: K1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2017
• Initial Report FDA Received Date: 06/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1