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	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that a falsely depressed sodium (na) result was obtained on a patient sample on a dimension exl with lm integrated chemistry system.Quality control (qc) was acceptable prior to the erroneous results.The customer replaced the integrated multisensor technology (imt) standard a, standard b and flush, ran imt calibration successfully.Siemens further evaluated the event and concluded that the air gap in the standard a and standard b tubing, likely introduced during priming after bottle replacement potentially contributed to the falsely depressed na result.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that a falsely depressed sodium (na) result was obtained on a patient sample on a dimension exl with lm integrated chemistry system.The initial result was not reported to the physician(s).The sample was repeated on an alternate dimension exl with lm integrated chemistry system.The repeat result recovered higher than the initial result and was considered correct.The repeat result was reported as correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed na result.

• 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.; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 24219872
• Report Number: 2517506-2026-00016
• Device Sequence Number: 8326031
• Product Code: JGS
• UDI-Device Identifier: 00842768014291
• UDI-Public: (01)00842768014291(10)5KD820(17)260418
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/30/2026

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: 01/13/2026
• Initial Report FDA Received Date: 01/30/2026
• 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