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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2024
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 depressed tacrolimus (tac) result was generated on a patient sample on a dimension exl 200 integrated chemistry system.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse verified system counter, checked the metering and flush of the sample syringe, replaced the tubing, checked the metering and tubing of the arm 2 syringe, performed alignments between the arm 2 to the heterogenous module (hm) vessel, and replaced the arm 2 ultrasonic mixer.The cause of the falsely depressed tac result is unknown.
Event or Problem Description
A falsely depressed tacrolimus (tac) result was generated on a patient sample on a dimension exl 200 integrated chemistry system.The erroneous result was not reported to physician.The sample was repeated on the same dimension exl 200 integrated chemistry system twice and both results recovered higher.The repeat results correlated with the patient¿s previous results and treatment status.The repeat results were reported to the physician, as the correct results.There is no known reports of patient intervention or adverse health consequences due to the falsely depressed tac result.
Additional Manufacturer Narrative
Siemens filed the initial mdr with the fda on 03-oct-2024.Additional information (17-sep-2024): in addition to the service activities mentioned in the initial report, the siemens customer service engineer (cse) replaced the sampler cable, sample syringes, and the tube between sample syringes, reagent (r2) probe, sample arm assembly, the solenoid in sample syringe section, the tube around the solenoid, the r2 transducer, the r2 syringes, and the tube around the r2 syringes.The cse also lubricated the sample syringe pump and sample arm shafts and adjusted the sample probe position and height.Additionally, the cse adjusted the r2 probe position, cleaned the quartz window, performed lamp calibration, aligned the arm alignment, and offset the mau.Then, the cse adjusted the sample probe and r2 probe positions and tested sample probe/r2 probe ultrasonic operation and liquid level detection.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2517506-2024-00261 on 03-oct-2024 and the first supplemental mdr on 15-oct-2024.Additional information (13-mar-2025): siemens further evaluated the event and determined quality control recovery was within acceptable range on the day of the incident and prior to the incident.The customer did not report discordant results for other patient samples.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 depressed tac result.The investigation findings code in section h6 was updated to reflect the additional information.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 07836
• Manufacturer Contact: douglas stanton ; 511 benedict avenue; tarrytown, NY 10591 ; 9142706592
• MDR Report Key: 20357972
• Report Number: 2517506-2024-00261
• Device Sequence Number: 20654112
• 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,Followup
• Report Date (Section B): 04/02/2025

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: 09/13/2024
• Supplement Date Received by Manufacturer: 09/17/2024; 03/13/2025
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/15/2024; 04/02/2025
• 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