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	01/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) and reported that erroneously depressed sodium (na) results were obtained on a dimension exl with lm system.Siemens concluded the investigation of the event.Siemens reviewed the available instrument data files and the information provided by the customer.A review of the instrument data indicated that the calibration was acceptable, quality control (qc) recovery was within the customer¿s expected ranges indicating that the na assay was performing acceptably.The customer replaced the salt bridge solution, primed all integrated multisensor technology (imt) consumables, rerun same patient samples which recovered acceptably.The cause of the event is consistent with flow issue through imt system and tubings with the formation of sample/fibrin clot, crystal formation, which was resolved by priming all imt consumables.The customer is operational.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
The customer reported to siemens that erroneously depressed sodium (na) results were obtained on two (2) patient samples on a dimension exl with lm system.The initial depressed results were not reported to the physician(s).The same samples were reprocessed on an alternate dimension exl 200 system and obtained higher results.The higher results matched the clinical picture of the patients, considered correct and were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed na results.

• 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: mekala g ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 840457474
• MDR Report Key: 21445653
• Report Number: 2517506-2025-00028
• Device Sequence Number: 7320218
• Product Code: JGS
• UDI-Device Identifier: 00842768014291
• UDI-Public: (01)00842768014291(10)4JD822(17)250329
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 02/24/2025

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: 03/29/2025
• Device Model Number: N/A
• Device Catalogue Number: S600 SMN 10445058
• Device Lot Number: 4JD822
• 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: 01/30/2025
• Initial Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2024
• 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