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

Model Number	N/A
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	06/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer saw a shift up in tni-ultra quality control (qc) results on the advia centaur cp system when they switched from tni-ultra lot 149 to 160.The customer ran a patient correlation and observed a shift up in patient results also.The siemens technical support center (tsc) assisted customer with troubleshooting.The customer was provided with customer bulletin restoration of alignment of tni-ultra on the advia centaur cp system to advia centaur/advia centaur xp/advia centaur xpt systems (b)(4), rev.A.The customer adjusted the qc range.As per customer bulletin - restoration of alignment of tni-ultra on the advia centaur cp system to advia centaur/advia centaur xp/advia centaur xpt systems (b)(4), rev.A, the positive shift is expected due to realignment of the advia centaur® cp immunoassay system to the advia centaur, advia centaur xp, and advia centaur xpt immunoassay systems for tni-ultra.The customer's results on the patient samples are similar to what was observed on the siemens' in house testing and provided in the customer bulletin.None of the samples changed clinical interpretation between the kit lots.Updated qc targets/ranges for kit lots 160 and higher are provided on the biorad website.The customer has updated their targets/ranges for biorad qc accordingly.There is no confirmed product performance issue.The assay works as specified and the customer is operational.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.".
Event or Problem Description
Discordant high advia centaur cp troponin ultra (tni-ultra) results were obtained for samples from five patients during a lot to lot correlation.The correlation was between tni-ultra lot 149 and lot 160.The results were higher with lot 160.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 CP 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: 8740919
• Report Number: 1219913-2019-00123
• Device Sequence Number: 1680543
• Product Code: MMI
• UDI-Device Identifier: 00630414516226
• UDI-Public: 00630414516226
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K053020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

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: 01/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 10317709
• Device Lot Number: 70528160
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1