MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR TNI-ULTRA ASSAY; TROPONIN I IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report a discordant, a falsely elevated advia centaur tni-ultra assay result obtained on a patient sample.Quality control (qc) results were within acceptable ranges.Siemens is investigating.The instruction for use (ifu) states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".
Event or Problem Description
A discordant, falsely elevated advia centaur tni-ultra assay result was obtained on a patient sample and questioned by the physician(s).The customer performed repeat testing on the same sample after centrifugation, resulting high.The same sample was tested on two alternate troponin test methods, resulting lower.The lower result agreed with what was expected.The lower result was reported to the physician(s) as a corrected result.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant, falsely elevated advia centaur tni-ultra assay result.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2021-00206 initial report on 19-mar-2021 for a discordant, falsely elevated advia centaur tni-ultra xp result obtained on a patient sample.26-mar-2021: additional information: siemens has completed the investigation.Quality control (qc) results were within acceptable ranges at the time the samples were run indicating a potential sample specific issue.The patient was not known to be taking biotin supplements and the result was not falsely depressed, so this is not considered to be a contributing factor.The patient sample could not be sent to siemens for further investigation such as heterophile binding tube preparation and/or serial dilutions.The potential cause of the discordant, falsely elevated advia centaur tni-ultra xp result may be due to an unknown interfering substance in the patient sample.Immunoassays are subject to a number of interferences including those caused by endogenous antibodies.Interference can occur because of heterophile antibodies, anti-animal antibodies and auto antibodies.Patients exposed to animals or animal serum products can be prone to this interference and anomalous values may be observed.The interfering antibodies can give rise to a falsely high or less commonly a falsely low result.The erroneous result is recognized as being inconsistent with the patient's clinical picture.The laboratory procedures generally used to identify the presence of interfering antibody are serial dilutions to demonstrate a nonlinear response.An interferent may not necessarily be due to an interfering antibody but may be due to other exogenous interferences such as drugs, nutritional supplements and/or herbal medicine in the blood.The assay is performing within specifications.No further evaluation of the device is required.In section h6, the investigation findings code and the investigation conclusion codes were revised.

• Brand Name: ADVIA CENTAUR TNI-ULTRA ASSAY
• Common Device Name: TROPONIN I IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 11529919
• Report Number: 1219913-2021-00206
• Device Sequence Number: 4510563
• Product Code: MMI
• UDI-Device Identifier: 00630414516226
• UDI-Public: 00630414516226
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K053020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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: 07/04/2021
• Device Model Number: N/A
• Device Catalogue Number: 10317709
• Device Lot Number: 183
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1