MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; DIMENSION® ENZYMATIC CARBONATE FLEX® REAGENT CARTRIDGE

Catalog Number	DF137 SMN 10444972
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding two erroneously elevated enzymatic carbonate (eco2) results obtained on a patient sample on a dimension exl 200 integrated chemistry system.Siemens is evaluating the event.
Event or Problem Description
The customer reported to siemens that they obtained two erroneously elevated enzymatic carbonate (eco2) results on a patient sample on a dimension exl 200 integrated chemistry system.The initial erroneously elevated result was not reported to the physician(s).The same sample was auto reprocessed on the original dimension exl 200 integrated chemistry system due to high panic flag on the initial result.The auto reprocessed result also recovered higher with the high panic flag, was considered erroneous, and was not reported to the physician(s).The same sample was reprocessed on the original dimension exl 200 integrated chemistry system and a lower result was obtained, considered correct, and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated enzymatic carbonate (eco2) results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2517506-2025-00094 on 11-jun-2025.Additional information (25-nov-2025): siemens healthcare diagnostics concluded the investigation of the event.Siemens evaluated the instrument data, and the information provided by the customer.Calibration and quality control (qc) recovered acceptably.Siemens reviewed the filter data and found foaming issues.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse inspected the system and replaced the reagent 1 (r1) arm, verified r1 alignments, performed reagent 2 (r2) probe alignments, ran system checks and qc, which recovered acceptably but the issue persisted.The cse verified laboratory temperature and humidity, which were within specification.The cse changed the settings so that other tests would aspirate first, except enzymatic carbonate (eco2), but the issue still persisted.Siemens proposed additional troubleshooting, but the customer declined, as they were auto-repeating samples that exceeded panic limits according to their standard laboratory procedure.Based on the available information, the cause of the event is unknown.A product problem was not identified.The customer is operational.The device is performing according to specifications.No further evaluation is required.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated to reflect the additional information.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® ENZYMATIC CARBONATE 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: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 22182495
• Report Number: 2517506-2025-00094
• Device Sequence Number: 8356104
• Product Code: KHS
• UDI-Device Identifier: 00842768005374
• UDI-Public: (01)00842768005374(10)GB6035(17)260204
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K010206
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: 02/04/2026
• Device Catalogue Number: DF137 SMN 10444972
• Device Lot Number: GB6035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown