MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; DIMENSION® EXL¿ WITH LM INTEGRATED CHEMISTRY SYSTEM

Model Number	DIMENSION® EXL¿ WITH LM
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding a falsely depressed sodium (na) result on a patient sample obtained on a dimension exl system.Siemens is investigating the event.
Event or Problem Description
A discordant falsely depressed sodium (na) result on a patient sample was obtained on a dimension exl system.The falsely depressed result was reported to the physician(s), who questioned the result.The same sample was reprocessed on an alternate dimension exl system, and the result was higher.The higher result was considered as correct result by the physician(s).A corrected report was issued.The patient was admitted to the hospital and placed on fluid restrictions due to the falsely depressed sodium (na) result.There are no known reports of adverse health consequences due to the falsely depressed sodium (na) result.
Additional Manufacturer Narrative
Additional information (18-dec-2023): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc evaluated the information provided by the customer and the instrument data logs.Calibration and quality control recovered within the customer's expected ranges.No issues were reported with other patient samples.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse performed maintenance that was part of standard troubleshooting including the replacement of several instrument parts relevant to issues of this nature.The issue was resolved after the standard troubleshooting.Repeat of the same samples yielded the expected results.Hsc concluded that the cause of the event is consistent with component failure.The customer is operational.The device is performing within specifications.No further evaluation is required.Sections h3 and h6 have been updated to reflect the hsc investigation.Initial mdr 2517506-2023-00270 was filed on 05-dec-2023.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® EXL¿ WITH LM INTEGRATED CHEMISTRY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 101 silvermine road; registration #: 1226181; brookfield CT 06804
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 610; newark, DE 19714-6101 ; 7372808688
• MDR Report Key: 18265393
• Report Number: 2517506-2023-00270
• Device Sequence Number: 15426534
• Product Code: JJE
• UDI-Device Identifier: 00842768030024
• UDI-Public: 00842768030024
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130276
• 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): 01/11/2024

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 Model Number: DIMENSION® EXL¿ WITH LM
• Device Catalogue Number: SMN 10472176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female