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	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from the united states reported an observation of a depressed sodium (na) result which was discordant relative to repeat testing.Siemens reviewed the instrument data and the information provided by the customer.Reagent and instrument issues were ruled out based on quality control (qc) recovery within acceptable ranges and no issues were reported with other patient samples.The customer replaced the sample diluent and flush consumables and stated that they did not observe any low volume, bubbles, or discoloration in these consumables during the event.Based on the available information, the cause of the discordant result was unable to be determined.The issue was resolved by routine troubleshooting.A product problem was not identified.The customer is operational and no further actions are required.
Event or Problem Description
The customer reported an observation of a depressed sodium (na) results which was discordant relative to repeat testing when using lot 5fd811.An initial depressed result was obtained for one (1) patient samples.The initial depressed result was not reported to the physician.The same sample was then retested on an alternate dimension exl system and obtained a higher result.The higher result was considered correct and was reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the reported event.

• 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: 23731933
• Report Number: 2517506-2025-00178
• Device Sequence Number: 18782262
• Product Code: JGS
• UDI-Device Identifier: 00842768014291
• UDI-Public: (01)00842768014291(10)5FD811(17)251129
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 12/05/2025

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: 11/29/2025
• Device Model Number: N/A
• Device Catalogue Number: 10445058
• Device Lot Number: 5FD811
• 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: 11/10/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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