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

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report discordant, falsely elevated advia centaur xp troponin i ultra (tni-ultra) results.Siemens has completed the incident investigation.It was noted that there were approximately ten troponin i ultra (tni-ultra) tests remaining in the original readypack (id# 14718) when the issue occurred, and that quality control (qc) had not been run on this readypack.The relative light units (rlus) on the original reagent readypack were observed to be elevated compared to the repeat results on the new reagent readypack (id# 15212).The customer stated that the original reagent readypack had been well mixed when first loaded on the system, and that reagent settling/clumps were not observed.The original reagent readypack was not available (no remaining tests) for further investigation, however siemens has reviewed the quality control (qc) in-house reagent lot 170 uniformity data and there is no indication of reagent readypack non-uniformity within the same reagent lot.Based on the information provided, the cause of the initially elevated patient results is unknown, however potential contributing factors such as shipping/handling/storage cannot be ruled out.The customer is operational.The instruction for use (ifu) states the following in the summary and explanation section: "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.A positive troponin result is not always indicative of mi.Other conditions resulting in myocardial cell damage can contribute to elevated cardiac troponin i levels.These conditions include, but are not limited to, myocarditis, cardiac surgery, angina, unstable angina, congestive heart failure, and non-cardiac related causes, such as, renal failure and pulmonary embolism." the ifu states the following 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." the assay is performing within specification.No further evaluation of the device is required.
Event or Problem Description
Discordant, falsely elevated advia centaur xp troponin i ultra (tni-ultra) initial results were obtained on four patient samples.The customer performed repeat tni-ultra testing on the same samples with a new reagent readypack from the same reagent lot number, resulting lower.The repeat tni-ultra results were reported to the physician(s) as the correct results.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant, falsely elevated advia centaur xp troponin i ultra (tni-ultra) results.

• Brand Name: ADVIA CENTAUR XP TROPONIN I ULTRA (TNI-ULTRA)
• Common Device Name: TROPONIN I IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10438024
• Report Number: 1219913-2020-00218
• Device Sequence Number: 19502078
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2020

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: 08/18/2020
• Device Model Number: N/A
• Device Catalogue Number: 10317709
• Device Lot Number: 170
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1