MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION; DIMENSION® TNIH LOCI 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	09/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding a discordant falsely elevated high-sensitivity troponin i (tnih) patient sample result obtained on a dimension vista 500 system.Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the event.Hsc concluded that based on the information provided in this complaint, the event was an operator use error.The operator did not enter the correct tnih assay correlation factors.Removal of the incorrect tnih assay correlation factors resolved the issue.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
A discordant falsely elevated loci high-sensitivity troponin i (tnih) patient sample result was obtained on a dimension vista 500 system.The discordant result was reported to the physician(s).The sample result was questioned and the sample was reprocessed after removal of correlation factors of the tnih assay.A lower result was obtained and a corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the discordant falsely elevated patient tnih result.

• Brand Name: DIMENSION
• Common Device Name: DIMENSION® TNIH LOCI 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: 12633253
• Report Number: 2517506-2021-00286
• Device Sequence Number: 4290053
• Product Code: MMI
• UDI-Device Identifier: 00842768037719
• UDI-Public: 00842768037719
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K182225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 10/14/2021

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: 04/21/2022
• Device Model Number: 10471067
• Device Catalogue Number: K6427 SMN 10471067
• Device Lot Number: 21176BC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1