MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. 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	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously elevated enzymatic carbonate (eco2) result obtained for one (1) patient on a dimension® exl 200 integrated chemistry system.Siemens is investigating the event.
Event or Problem Description
The customer reported to siemens they obtained an erroneously elevated enzymatic carbonate (eco2) result on one (1) patient sample on a dimension® exl¿ 200 integrated chemistry system.The erroneously elevated result was not reported to the physician.The same sample was reprocessed on the same dimension® exl¿ 200 integrated chemistry system.A lower result was obtained, considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated enzymatic carbonate (eco2) result.
Additional Manufacturer Narrative
Additional information (30-jan-2025): siemens healthcare diagnostics headquarters service operations support (sos) concluded the investigation of the event.Sos reviewed the instrument data and the information provided by the customer.A customer service engineer (cse) performed routine troubleshooting actions on the dimension exl 200 instrument.No discordant results were reported by the customer after these routine service actions were completed.The cause of the event is unknown.A potential product issue was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.In section h6, the investigation finding and the investigation conclusion codes were updated.Initial mdr 2517506-2025-00002 was filed 06-jan-2025.

• Brand Name: DIMENSION
• Common Device Name: 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: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 21080002
• Report Number: 2517506-2025-00002
• Device Sequence Number: 15550048
• Product Code: KHS
• UDI-Device Identifier: 00842768005374
• UDI-Public: (01)00842768005374(10)BA5182(17)250701
• Combination Product (Y/N): N
• 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): 02/09/2025

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: 07/01/2025
• Device Model Number: N/A
• Device Catalogue Number: 10444972
• Device Lot Number: BA5182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/31/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 02/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2024
• 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