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

Model Number	DIMENSION® EXL¿ 200 SYSTEM
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
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 enzymatic creatinine (ezcr) patient sample result obtained on a dimension® exl¿ 200 integrated chemistry system.Siemens is investigating the event.
Event or Problem Description
A discordant falsely depressed enzymatic creatinine (ezcr) patient sample result was obtained on a dimension® exl¿ 200 integrated chemistry system.The falsely depressed result was not reported to the physician.The same sample was reprocessed on the original system and a higher result was obtained, considered correct and reported.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed ezcr result.
Additional Manufacturer Narrative
Correction section b3.Date of event corrected from 03-mar-2023 to 02-mar-2023.Additional information (14-mar-2023): 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.Repeat of the same sample yielded expected results.No product non-conformance was identified with the enzymatic creatinine (ezcr) assay or the dimension exl 200 system.A potential product issue was not identified.The cause of the event is unknown.The customer is fully operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2517506-2023-00095 was filed on 15-mar-2023.

• 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; 101 silvermine road; registration number: 1226181; brookfield CT 06804
• Manufacturer Contact: helen bouchard ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 16547830
• Report Number: 2517506-2023-00095
• Device Sequence Number: 6042601
• Product Code: JJE
• UDI-Device Identifier: 00842768037214
• UDI-Public: 00842768037214
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K130276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 05/09/2023

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 SYSTEM
• Device Catalogue Number: SMN 10636928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2012
• 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 Sex: Male