MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM 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	05/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report a discordant, falsely elevated atellica im troponin i ultra (tni-ultra) result on a patient sample.A siemens customer service engineer (cse) was dispatched to the customer site for system inspection.The cse on inspection, observed bubbles in the wash manifold coming from the wash displacement (wswd) line.All wswd associated valves and the wswd pump, input and output fittings were replaced.Reagent probe 1 was replaced to improve the dispense test.The luminometer, wash block 1 and wash block 2 were removed and cleaned.The secondary vacuum regulator was reset, and the instrument was primed.An auto-check was performed, calibration and quality control (qc) were acceptable.The analyzer was fully functional on departure and returned to service.There have been no additional issues reported by the customer since the service visit.A potential product issue was not identified.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." the assay is performing within specification.No further evaluation of the device is required.
Event or Problem Description
A discordant, falsely elevated atellica im troponin i ultra (tni-ultra) result was obtained by the customer on a patient sample.The same sample was repeated on the original atellica im system and on another atellica im system, all resulting lower.The lower tni-ultra result was reported to the physician(s) as the correct result.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant, falsely elevated atellica im troponin i ultra (tni-ultra) result.

• Brand Name: ATELLICA IM 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: 10165618
• Report Number: 1219913-2020-00145
• Device Sequence Number: 3573282
• Product Code: MMI
• UDI-Device Identifier: 00630414600093
• UDI-Public: 00630414600093
• Combination Product (Y/N): N
• 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): 06/17/2020

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: 10995696
• Device Lot Number: 169
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 06/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1