MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION QUIKLYTE INTEGRATED MULTISENSOR NA+ / K+ / CL-; ELECTRODE, ION SPECIFIC, SODIUM

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	04/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously depressed sodium (na) patient sample results obtained on a dimension exl with lm integrated chemistry system.Siemens healthcare diagnostics service operations support (sos) concluded the investigation of the event.Sos reviewed the information provided by the customer.No reagent issues were identified.Quality control (qc) was within the customer¿s acceptable ranges.Per siemens' recommendations, the customer performed a variety of troubleshooting steps on the instrument and observed a high pump rate.The customer replaced the x tubing, manually adjusted the imt pump rate, ran conditioning, ran a dilution check with a new bottle, and ran an additional dilution check.The customer stated the issue was resolved with these troubleshooting steps and no other discordant results were reported.The customer is operational.The device is performing within specifications.A potential product issue was not identified.No further evaluation is required.
Event or Problem Description
The customer reported to siemens they obtained erroneously depressed sodium (na) results on two (2) patient samples on a dimension exl with lm integrated chemistry system.The erroneously depressed results were reported to the physicians and not questioned.The same samples were reprocessed on the original dimension exl with lm integrated chemistry system.Higher results were obtained, considered correct, and reported to the physicians in amended reports.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed sodium (na) results.

• Brand Name: DIMENSION QUIKLYTE INTEGRATED MULTISENSOR NA+ / K+ / CL-
• Common Device Name: ELECTRODE, ION SPECIFIC, SODIUM
• 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: isaac dashefsky ; 500 gbc drive; po box 6101; newark, DE 19714-6101 ; 9173315804
• MDR Report Key: 24953292
• Report Number: 2517506-2026-00072
• Device Sequence Number: 16031048
• Product Code: JGS
• UDI-Device Identifier: 00842768014291
• UDI-Public: (01)00842768014291(10)5MD823(17)260606
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Report Date (Section B): 04/22/2026

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: 06/06/2026
• Device Model Number: N/A
• Device Catalogue Number: 10445058
• Device Lot Number: 5MD823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2026
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown