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	09/21/2023
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 total bilirubin (tbi) sample 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 information provided by the customer and instrument data files.Calibration and quality control were within customer¿s acceptable range and no issues were reported with other patient samples.The cause of the event is unknown.A potential product issue has not been identified.The customer is fully operational.The device is performing according to specifications.No further evaluation is required.
Event or Problem Description
A discordant falsely depressed total bilirubin (tbi) patient sample result was obtained on a dimension® exl¿ 200 integrated chemistry system.The falsely depressed patient sample result was reported to the physician and was questioned.The same sample was reprocessed on the same dimension® exl¿ 200 integrated chemistry system.On (b)(6) 2023 the same sample was reprocessed in triplicate on the same dimension® exl¿ 200 integrated chemistry system for troubleshooting purposes only.On (b)(6) 2023 and (b)(6) 2023 additional patient samples from the same patient were drawn and processed on the same dimension® exl¿ 200 integrated chemistry system.The higher reprocessed result obtained was considered correct and reported to the physician.There are no known reports of patient intervention and adverse health consequences due to the falsely depressed total bilirubin (tbi) 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.; 101 silvermine road; registration #: 1226181; brookfield, CT 06804
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 17974538
• Report Number: 2517506-2023-00224
• Device Sequence Number: 19446445
• 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): 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): 10/20/2023

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: 09/26/2023
• Initial Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2016
• 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: 7 DA
• Patient Sex: Female