MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA; DIMENSION VISTA® CTNI CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE

Model Number	10445098
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center regarding a falsely elevated cardiac troponin i patient result.Siemens headquarters support center (hsc) has concluded their investigation of this event.The instrument data log was reviewed and no product non-conformance was identified with the instrument or assay.The event was due to the customer diluting a below assay range cardiac troponin i (ctni) sample using the special dilution feature (auto-dilution) on the dimension vista system and recovered a result of 0.0750 ug/l.The investigation concluded that the customer failed to follow the instruction in the dimension vista operator's guide regarding how to resolve below assay range flagged results.The cause of the event is use error.The device is performing within specifications.No further evaluation of the device is necessary.
Event or Problem Description
A discordant, falsely elevated cardiac troponin (ctni) patient sample result was obtained on a dimension vista® 500 system.The initial result was not reported, but was reprocessed with an auto-dilution.The diluted sample resulted higher than the initial result, and that result was reported.The customer realized that the reprocessed result was discordant and issued a corrected report with the initial result.There are no known reports of patient intervention, or adverse health consequences due to the discordant ctni result.

• Brand Name: DIMENSION VISTA
• Common Device Name: DIMENSION VISTA® CTNI CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 10871460
• Report Number: 2517506-2020-00337
• Device Sequence Number: 17144188
• Product Code: MMI
• UDI-Device Identifier: 00842768015151
• UDI-Public: 00842768015151
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K063756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 11/19/2020

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: 02/25/2021
• Device Model Number: 10445098
• Device Catalogue Number: K6421 SMN 10445098
• Device Lot Number: 20118BD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1