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

Model Number	DIMENSION® EXL¿ WITH LM INTEGRATED CHEMISTRY SYSTEM
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A discordant falsely elevated cardiac troponin i (tni) patient result was obtained on a dimension® exl¿ with lm integrated chemistry system.The falsely elevated result was reported to the physician, and the result was questioned.Additionally, a new sample was drawn from the same patient and processed on the same dimension exl with lm system.Lower results were obtained and considered correct.A corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the reported issue.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a falsely elevated cardiac troponin i (tni) patient result obtained on a dimension® exl¿ with lm integrated chemistry system.Siemens is investigating the event.
Additional Manufacturer Narrative
Additional information (06-dec-2023): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the available instrument data files and the information provided by the customer.Quality control (qc) recovered within customer's acceptable ranges and no issues were reported with other patient samples.A new sample drawn from the same patient produced an acceptable result when processed, indicating a sample integrity issue with the initial sample.Hsc concluded the cause of the event is consistent with a sample integrity issue.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2432235-2023-00318 was filed on 07-dec-2023.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® EXL¿ WITH LM 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: 18282868
• Report Number: 2432235-2023-00318
• Device Sequence Number: 14929984
• Product Code: JJE
• UDI-Device Identifier: 00842768030024
• UDI-Public: 00842768030024
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 12/26/2023

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¿ WITH LM INTEGRATED CHEMISTRY SYSTEM
• Device Catalogue Number: SMN 10472176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 12/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 79 YR
• Patient Sex: Female