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

Catalog Number	S600 SMN 10445058
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding two (2) erroneously depressed sodium (na) results obtained on a patient sample on a dimension exl 200 integrated chemistry system.Siemens is evaluating the event.
Event or Problem Description
The customer reported to siemens that they obtained two (2) erroneously depressed sodium (na) results on a patient sample on a dimension exl 200 integrated chemistry system.The initial result obtained was critically low and the same sample was auto reprocessed on the same dimension exl 200 integrated chemistry system.The auto reprocessed result recovered low and was considered erroneous.The auto reprocessed result was reported to the physician and was questioned.The same sample was reprocessed on the same dimension exl 200 integrated chemistry system on the next day and a higher result was obtained.The higher reprocessed result was considered correct and reported to the physician.On the event date, a new sample was drawn from the same patient and processed on the same dimension exl 200 integrated chemistry system and a higher result was obtained.The same redrawn sample was reprocessed on the same dimension exl 200 integrated chemistry system on the next day and a higher result was obtained.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed sodium (na) results.
Additional Manufacturer Narrative
Additional information (03-mar-2025): siemens healthcare diagnostics concluded the investigation of the event.Siemens reviewed the information provided by the customer and instrument data files.Quality control (qc) and calibration recovered within the customer¿s expected ranges, indicating that the sodium (na) assay was performing acceptably and also no issues with sample integrity.No instrument errors were observed at the time of the event.The cause of the event is unknown.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.Initial mdr 2517506-2025-00029 was filed on 25-feb-2025.

• 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: 21456947
• Report Number: 2517506-2025-00029
• Device Sequence Number: 7680250
• Product Code: JGS
• UDI-Device Identifier: 00842768014291
• UDI-Public: (01)00842768014291(10)4KD823(17)250426
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: 04/26/2025
• Device Catalogue Number: S600 SMN 10445058
• Device Lot Number: 4KD823
• 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: 01/31/2025
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2024
• 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