MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION; DIMENSION QUIKLYTE INTEGRATED MULTISENSOR

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that erroneously depressed sodium (na) results were obtained on three patient samples after standard a replacement on a dimension exl with lm integrated chemistry system.Quality control (qc) was out of range on the event date.Siemens is evaluating the event.
Event or Problem Description
The customer reported that erroneously depressed sodium (na) results were obtained on three patient samples after standard a replacement on a dimension exl with lm integrated chemistry system.The erroneous results were reported to the physician(s), who questioned the results.The samples were reprocessed on the original system.The reprocessed results were higher than the erroneous results and correlated with the patient's history.The reprocessed results were reported as the correct results to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed sodium (na) results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2517506-2026-00054 on 20-mar-2026.Additional information (25-mar-2026): siemens concluded the investigation of the event.Siemens reviewed the instrument data files, and the information provided by the customer.Quality control (qc) was within range before replacing standard a (std a), and it was out of range after the replacement.The customer ran qc again, which recovered acceptably.Siemens reviewed the instrument data and determined that the air and liquid values of std a and standard b (std b) were within the normal range, and that the calibration was acceptable with lytes slope in range on the day of event.The customer adjusted the integrated multisensor technology (imt) pump rate.Siemens evaluated the event and determined that std a flow issue potentially contributed to the erroneously depressed sodium (na) results, which was corrected by automatic priming by the imt system.A product problem was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the siemens investigation.

• Brand Name: DIMENSION
• Common Device Name: DIMENSION QUIKLYTE INTEGRATED MULTISENSOR
• 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: 24646766
• Report Number: 2517506-2026-00054
• Device Sequence Number: 9842577
• Product Code: JGS
• UDI-Device Identifier: 00842768014291
• UDI-Public: (01)00842768014291(10)5KD820(17)260418
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K112999
• 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): 04/16/2026

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: 04/18/2026
• Device Model Number: N/A
• Device Catalogue Number: 10445058
• Device Lot Number: 5KD820
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2025
• 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