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

Model Number	DIMENSION® EXL¿ WITH LM
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A discordant falsely elevated enzymatic creatinine (ezcr) patient sample result was obtained on a dimension exl with lm system.The falsely elevated result was reported to the physician(s), and the result was questioned.The patient was sent to another facility, where a new sample was drawn from the same patient and processed on an alternate system.A lower result, considered correct, was obtained.Additionally, the original sample was reprocessed on the original dimension exl with lm system at the customer site, and a lower result, considered correct, was obtained.A corrected report was issued.The customer stated that the patient was transferred to an alternate facility due to the falsely elevated ezcr result.There are no known reports of unnecessary treatment or adverse health consequences due to the falsely elevated ezcr result or patient transfer.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a falsely elevated enzymatic creatinine (ezcr) patient sample result obtained on a dimension exl with lm system.Siemens is investigating the event.
Additional Manufacturer Narrative
Additional information (18-may-2023): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the information provided by the customer.Quality control (qc) results were within the customer's expected ranges and no issues were noted with other patient samples indicating that the dimension exl with lm system and enzymatic creatinine (ezcr) assay were performing acceptably.Repeat of the same sample yielded the expected result(s).A potential product issue was not identified.The cause of the event is unknown.The system is fully functional.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2517506-2023-00147 was filed on 03-may-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: 16859155
• Report Number: 2517506-2023-00147
• Device Sequence Number: 6865731
• Product Code: JJE
• UDI-Device Identifier: 00842768030024
• UDI-Public: 00842768030024
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 06/08/2023

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
• 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: 04/19/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2013
• 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: Female