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

Model Number N/A

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2024

Event Type  malfunction  

Manufacturer Narrative

An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a falsely depressed high sensitivity troponin i (tnih) result obtained on a patient sample on a dimension exl 200 system.Siemens healthcare diagnostics concluded the investigation of the event.Siemens has evaluated the instrument data and the information provided by the customer.Quality control (qc) was within expected ranges at the time of the event and there were no issues with calibration.Siemens reviewed the loci data and observed no issues with the loci performance.Siemens reviewed the clot check data and observed there is aspiration pressure shifting high which suggesting the micro clots present in the affected patient sample.The probable cause of the issue was consistent with the sample integrity or micro clots present in the sample.Repeat of the same sample yielded the expected results.No similar events with other patient samples were observed.A potential product issue was not identified.The customer is operational.

Event Description

A discordant falsely depressed high sensitivity troponin i (tnih) result was obtained on a patient sample on a dimension exl 200 system.The falsely depressed result was reported to the physician and was questioned.The same sample was reprocessed on the same system and obtained a higher result.The higher result was considered correct and issued on the corrected report.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed high sensitivity troponin i (tnih) result.

• Brand Name: DIMENSION®
• Type of Device: DIMENSION®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
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: eiman sulieman ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 18887831
• MDR Text Key: 337746443
• Report Number: 2517506-2024-00093
• Device Sequence Number: 1
• Product Code: MMI
• UDI-Device Identifier: 00842768037726
• UDI-Public: 00842768037726
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K190675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2024
• Device Model Number: N/A
• Device Catalogue Number: SMN 10471068
• Device Lot Number: FA4079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male