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

Model Number	10445098
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the falsely depressed cardiac troponin i (ctni) result.Hsc concluded the customer did not follow the dimension vista operator's guide instructions for handling a measurement error result flag.The issue was resolved by following the dimension vista operator's guide instructions which allowed the customer to identify the presence of a patient specific interferent.The device is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely depressed patient sample cardiac troponin i (ctni) result was obtained on a dimension vista® 500 system on a sample dilution processed after an initial measurement error flag was obtained.The discordant result was reported to the physician.The same sample was reprocessed on an alternate dimension vista® 500 system and a measurement error flag was obtained.The same sample was processed on an alternate instrument, at an alternate site and a higher ctni result was obtained.The reprocessed, higher ctni result was considered correct and was reported to the physician.There were no reports of patient intervention or adverse health consequences due to the falsely depressed ctni result.

• Brand Name: DIMENSION VISTA
• Common Device Name: CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6104
• MDR Report Key: 12462680
• Report Number: 2517506-2021-00250
• Device Sequence Number: 1245707
• Product Code: MMI
• UDI-Device Identifier: 00842768015151
• UDI-Public: 00842768015151
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2021

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: 01/03/2022
• Device Model Number: 10445098
• Device Catalogue Number: K6421 SMN10445098
• Device Lot Number: 21064BB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR