MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL 200 QUIKLYTE® INTEGRATED MULTISENSOR; 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	09/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously depressed sodium (na) patient result obtained on 1 (one) patient sample on a dimension® exl¿ 200 integrated chemistry system.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc evaluated the information provided by the customer and the available instrument data files.Quality control (qc) recovered within the customer's acceptable ranges.No reagent or instrument issues were identified.The cause of the event is unknown.The customer is operational.The device is performing within specifications.A potential product issue was not identified.No further evaluation is required.
Event or Problem Description
The customer reported one (1) erroneously depressed sodium (na) patient sample result with a quiklyte integrated multisensor (imt) on a dimension® exl¿ 200 integrated chemistry system.The erroneously depressed sodium (na) result was reported to the physician(s) and questioned.The same sample was reprocessed on an alternate dimension® exl¿ 200 integrated chemistry system.A higher result was obtained, considered correct, and reported as an amended result to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed sodium (na) result.

• Brand Name: DIMENSION EXL 200 QUIKLYTE® INTEGRATED MULTISENSOR
• 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: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 20324565
• Report Number: 2517506-2024-00238
• Device Sequence Number: 20834425
• Product Code: JGS
• UDI-Device Identifier: 00842768014291
• UDI-Public: (01)00842768014291(10)4DD810(17)241012
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 09/27/2024

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: 10/12/2024
• Device Model Number: N/A
• Device Catalogue Number: 10445058
• Device Lot Number: 4DD810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 09/27/2024
• Date Device Manufactured: 04/15/2024
• 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 Age: 41 YR
• Patient Sex: Female