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

Model Number	10471067
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding discordant, falsely elevated high-sensitivity troponin i (tnih) patient results obtained on a dimension vista 1500 instrument.Siemens is investigating the event.
Event or Problem Description
Discordant, falsely elevated high-sensitivity troponin i (tnih) results were obtained on patient samples on a dimension vista 1500 instrument.The discordant results were reported to the physician(s).The customer reprocessed the samples after quality control was detected outside of laboratory acceptance range.Lower results, considered correct, were obtained.Corrected reports were issued.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated tnih results.
Additional Manufacturer Narrative
Initial mdr 2517506-2021-00102 was filed (b)(6) 2021 siemens healthcare diagnostics headquarters support center concluded the investigation of the falsely elevated high-sensitivity troponin i (tnih) patient results obtained on a dimension vista 1500 instrument.Hsc reviewed the instrument data logs.The event involved a single flex reagent cartridge of the dimension vista high sensitivity troponin i (tnih) reagent lot 20244ba which produced higher results compared to repeat results with other tnih flex reagent cartridges from the same lot processed on the same analyzer.This event was identified by the customer when processing tnih quality control (qc) and the customer discarded the reagent cartridge.The event was not consistent with an instrument malfunction.No similar events were reported with other tnih flex reagent cartridges in use at the customer site.The event was isolated to the single tnih flex reagent cartridge that was discarded by the customer.The cause of the event is unknown.The customer is operational.The device is performing within specifications.No further evaluation is required.

• Brand Name: DIMENSION VISTA
• Common Device Name: HIGH SENSITIVITY 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: 11680432
• Report Number: 2517506-2021-00102
• Device Sequence Number: 17199938
• Product Code: MMI
• UDI-Device Identifier: 00842768037719
• UDI-Public: 00842768037719
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K182225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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: 06/27/2021
• Device Model Number: 10471067
• Device Catalogue Number: K6427 SMN 10471067
• Device Lot Number: 20244BA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1