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

Model Number	N/A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens reviewed the information provided by the customer.The quality control (qc) was in range at the time the sample was run.The customer ran the sample on a heterophile binding tube (hbt) tube - this did not decrease the result, it remained elevated indicating that a heterophile antibody is not present in the sample.There was not sufficient sample to send to siemens for any further testing.Based on information provided, an interfering substance in the sample cannot be ruled out, causing the elevated result on the advia centaur xp and not on the dimension exl.The dimension troponin i method uses different antibodies and has different specificity therefore may not be susceptible to the same interference seen with this sample.Immunoassays are subject to a number of interferences including those caused by endogenous antibodies and also other exogenous interferences such as drugs, nutritional supplements and/or herbal medicine in the blood.This issue was isolated to this patient sample.Based on the investigation, no product problem was identified.The instrument is performing within specifications.No further evaluation of the device is required.The instruction for use (ifu) under the summary and explanation of the test section states the following: "always analyze ctni results in the context of time elapsed since patient presentation to the hospital.Serial sampling is recommended to detect the temporal rise and fall of troponin levels characteristic of mi.In accord with published recommendations, serial testing of ctni at intervals of 2 to 4 hours for up to 12 to 24 hours is suggested to corroborate a single ctni result.An elevated troponin alone is not sufficient to make the diagnosis of mi.Other markers, such as ck-mb and myoglobin, can be used in conjunction with ctni results in aiding the diagnosis of mi." mdr 1219913-2019-00042 was filed for the same event (sid (b)(6)).
Event or Problem Description
A false positive advia centaur xp troponin ultra (tni-ultra) result was obtained for a patient sample on (b)(6) 2019.The patient sample was repeated and the result was positive.The positive result was reported to the physician and questioned.The physician sent the patient to (b)(6) hospital where another sample was obtained and tested for troponin on an alternate method.The result was negative.The patient had a sample collected on (b)(6) 2019 and tested on the advia centaur xp for tni-ultra.The result was positive.The sample was repeated and the result was positive.The result was reported to the physician and was questioned.The sample was sent internally to a branch laboratory for analysis on the siemens dimension exl and the result was negative.A corrected report was issued.The patient did not have any clinical features of a cardiac event.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant tni-ultra result.

• Brand Name: ADVIA CENTAUR XP TNI-ULTRA ASSAY
• Common Device Name: TROPONIN IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 8441528
• Report Number: 1219913-2019-00041
• Device Sequence Number: 11207813
• Product Code: MMI
• UDI-Device Identifier: 00630414516226
• UDI-Public: 00630414516226
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K053020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2019

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: 04/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 10317709
• Device Lot Number: 54907139
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR