MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM

Model Number	DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a falsely depressed valproic acid (valp) patient result obtained on a dimension® exl¿ 200 integrated chemistry system.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the instrument data logs and the information provided by the customer.Quality control (qc) was within expected ranges.Hsc observed that the issue was consistent with preanalytical variables.The cause of the event is unknown.A potential product issue was not identified.The customer is fully operational.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
A discordant falsely depressed valproic acid (valp) patient sample result was obtained on a dimension® exl¿ 200 integrated chemistry system.The falsely depressed patient result was not reported to the physician.The same sample was reprocessed on the same dimension® exl¿ 200 integrated chemistry system in triplicate and the results obtained were considered correct.The same sample was also reprocessed on an alternate non-siemens system.The reprocessed result from an alternate non-siemens system was considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed valproic acid (valp) patient result.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® EXL¿ 200 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.; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 17372113
• Report Number: 2517506-2023-00161
• Device Sequence Number: 17109602
• Product Code: JJE
• UDI-Device Identifier: 00842768037214
• UDI-Public: 00842768037214
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• 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
• Report Date (Section B): 07/21/2023

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¿ 200 INTEGRATED CHEMISTRY SYSTEM
• Device Catalogue Number: SMN 10636928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 07/21/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Sex: Female