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	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously depressed sodium (na) patient sample result 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 and the data from the instrument.No reagent or instrument issues were identified.The customer observed a consumable empty message for std a (quiklyte standard a).The customer replaced the std a and observed erroneously depressed results.The customer reran the quality control (qc) which recovered low out of the laboratory range.The customer then primed std a at least 10x and reran the qc which recovered within range.Sos reviewed the instrument data files and found low flow for std a fluid.This suggests a flow issue in the std a tubing, possibly due to bubbles, debris, buildup or wear.The depressed sodium (na+) result is consistent with this issue, which was resolved by priming std a during routine troubleshooting.A potential product issue was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
The customer reported to siemens an erroneously depressed sodium (na+) result obtained on one (1) patient sample on a dimension exl with lm integrated chemistry system.The erroneously depressed result was reported to the physician and not questioned.The same sample was reprocessed on an alternate dimension exl with lm integrated chemistry system.A higher result was obtained, considered correct and not reported.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed sodium (na+) result.

• 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: eiman sulieman ; 500 gbc drive; po box 6101; newark, DE 19714-6101 ; 7372808688
• MDR Report Key: 25034357
• Report Number: 2517506-2026-00078
• Device Sequence Number: 9039932
• Product Code: JGS
• UDI-Device Identifier: 00842768014291
• UDI-Public: (01)00842768014291(10)5LD822(17)260516
• 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
• Report Date (Section B): 04/29/2026

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: 05/16/2026
• Device Model Number: N/A
• Device Catalogue Number: 10445058
• Device Lot Number: 5LD822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/30/2025
• 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: A
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Sex: Female