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

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that falsely elevated enzymatic carbonate (eco2) results were obtained on two patient samples on a dimension exl 200 integrated chemistry system.The initial results were not reported to the physician(s).The samples were retested on the same system.The repeat results recovered lower than the initial results, and were considered correct as the results were within patient's reference range.These repeat results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated eco2 results.
Additional Manufacturer Narrative
A united states (us) customer contacted siemens customer care center (ccc) and reported that falsely elevated enzymatic carbonate (eco2) results were obtained on two patient samples on a dimension exl 200 integrated chemistry system.Quality control (qc) was within range on the date of the event.Siemens is evaluating the event.
Additional Manufacturer Narrative
Siemens filed the initial mdr on 12-sep-2025.Additional information (27-nov-2025): siemens reviewed the analyzer data and observed calibration and quality control (qc) to be within the range.A review of filter data indicated foaming was observed with indicator assays.A siemens customer service engineer (cse) was dispatched to the customer site.During the visit, the cse replaced the reagent 1 (r1) arm, verified r1 alignments, performed reagent 2 (r2) probe alignments, ran system checks and qc which recovered within specifications.Further, the cse verified laboratory temperature and humidity, which were within specification.Siemens evaluated the event and stated that the probable cause of the falsely elevated discordant enzymatic carbonate (eco2) results is inconclusive.The customer is operational by using the automatic rerun option for samples above panic range.No further evaluation of this device is required.Note: the investigation findings and investigation conclusion codes in the h6 sections were 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: 23035447
• Report Number: 2517506-2025-00143
• Device Sequence Number: 9682564
• Product Code: KHS
• UDI-Device Identifier: 00842768005374
• UDI-Public: 00842768005374
• 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): 12/19/2025

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 Model Number: N/A
• Device Catalogue Number: 10444972
• Device Lot Number: UNKNOWN
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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