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	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a falsely depressed tacrolimus (tac) result was obtained on a patient sample on a dimension exl 200 integrated chemistry system.The erroneous result was not reported to the physician(s).The sample was repeated on the original dimension exl 200 integrated chemistry system twice.The repeat results recovered higher than the erroneous result and correlated to the patient¿s clinical picture.The repeat result of 5.5 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 depressed tac result.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc) and reported that a falsely depressed tacrolimus (tac) result was obtained on a patient sample on a dimension exl 200 integrated chemistry system.Quality control (qc) was within range on the day of the event.Siemens remotely reviewed the instrument data and determined the sample absorbance test recovered acceptably.Then, siemens adjusted the height of the sample probe and lowered the suction position.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.The instrument is performing according to specifications.No further evaluation of this device is required.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2517506-2024-00245 on 02-oct-2024.Additional information (on 13-mar-2025): siemens reviewed the instrument data and determined the calibration was acceptable.The customer did not report discordant results for the other patient samples.Siemens evaluated the event and determined that there was no evidence of a reagent issue, photometer issue, water quality issue, or reagent/sample pipetting/delivery issues on the instrument 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 device manufacture date was missed in the initial mdr and section h4 was updated to provide device manufacture date.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: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka, NY 56010-3 ; IN 560103 ; 9086354191
• MDR Report Key: 20353439
• Report Number: 2517506-2024-00245
• Device Sequence Number: 6518114
• 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): 04/04/2025

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