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	02/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Three (3) discordant falsely depressed total bilirubin (tbi) patient sample results were obtained on a dimension® exl¿ 200 integrated chemistry system.The falsely depressed results were reported to the physician(s) and were questioned.The same samples were reprocessed on an alternate dimension® exl¿ 200 integrated chemistry system and higher results were obtained.The higher results were reported to the physician(s) on corrected reports.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed tbi results.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding the falsely depressed total bilirubin (tbi) patient sample results obtained on a dimension® exl¿ 200 integrated chemistry system.Siemens is investigating the event.
Additional Manufacturer Narrative
Additional information ((b)(6) 2023): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the information provided by the customer and the instrument data.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse performed maintenance that was part of standard troubleshooting for issues of this nature.Hsc concluded that the cause of the event was due to operator error when processing samples in small sample container (ssc) cups in the primary tube sample mode.The issue was resolved with operator training and verification of the dimension exl 200 system performance by the cse.A potential product issue was not identified.The customer is fully operational.The device is performing within specifications.No further evaluation is required.Sections h3 and h6 have has been updated to reflect the hsc investigation.Initial mdr 2517506-2023-00085 was filed on 10-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; 62 flanders bartley rd; registration#: 2247117; flanders NJ 07836
• Manufacturer Contact: helen bouchard ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 16524898
• Report Number: 2517506-2023-00085
• Device Sequence Number: 16730183
• Product Code: JJE
• UDI-Device Identifier: 00842768037214
• UDI-Public: 00842768037214
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 04/07/2023

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): Initial
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2019
• 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: Unknown