MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM

Model Number	DIMENSION EXL 200 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	10/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc) to report that a falsely elevated tacrolimus (tac) result was generated on a patient sample on a dimension exl 200 integrated chemistry system.Quality controls (qcs) recovered within ranges on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse replaced the light source lamp and the optical filter.The cse also cleaned the quartz window, calibrated the lamp, aligned the arm, and performed a milli absorbance readings (mau) offset and a recalibration.The cause of the falsely elevated tac result is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that a patient sample was processed for tacrolimus (tac) on a dimension exl 200 integrated chemistry system and a result of 17.33 ng/ml was obtained.Then, the sample was repeated on the same instrument and the repeat result recovered falsely elevated.The falsely elevated tac result was reported to the physician(s).As per the laboratory¿s setup, since the repeat result recovered above 20 ng/ml, the sample was manually diluted and repeated on the same instrument.The repeat result recovered lower.The neat sample was repeated again on the same instrument and a result of 14.24 ng/ml was obtained.The result of 14.24 ng/ml was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated tac result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2517506-2024-00287 on 15-nov-2024.Additional information (14-mar-2025): siemens further evaluated the event and determined there is no evidence of a reagent issue, photometer issue, water quality issue, or reagent/ sample pipetting/delivery issues on the analyzer that contributed to the erroneous tacrolimus (tac) result.Siemens determined the photometric data demonstrates indications of sample integrity issues, which potentially contributed to the falsely elevated tac result.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM
• 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 07839
• Manufacturer Contact: kristin kehyaian ; 511 benedict ave.; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 20694439
• Report Number: 2517506-2024-00287
• Device Sequence Number: 12384257
• Product Code: JJE
• UDI-Device Identifier: 00842768037214
• UDI-Public: (01)00842768037214
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/26/2025

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: 10636928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2019
• 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