MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	DIMENSION EXL
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted siemens to report that one falsely depressed troponin (tnih) result was obtained on a patient sample tested on a dimension exl analyzer.The customer reported that the dimension exl analyzer had cuvette forming errors.A siemens regional support center (rsc) specialist connected remotely to the customer site and worked with the customer to resolve the cuvette forming issue.The cause of the falsely depressed tnih test result is unknown.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.
Event or Problem Description
The customer contacted siemens and reported that one falsely depressed troponin (tnih) result was obtained on a patient sample tested on a dimension exl analyzer.The result was released to the physician(s).The same sample was repeated on the same analyzer and the repeat result was higher and released as the correct result to the physician(s).There are no reports of injury due to the event.

• Brand Name: DIMENSION EXL
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• 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: karl aebig ; 511 benedict ave; tarrytown, NY 10591
• MDR Report Key: 19832256
• Report Number: 2517506-2024-00199
• Device Sequence Number: 8159586
• Product Code: JJE
• UDI-Device Identifier: 00842768030024
• UDI-Public: (01)00842768030024
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2024

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
• Device Catalogue Number: 10472176
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 07/25/2024
• Date Device Manufactured: 01/19/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male