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	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a falsely depressed valproic acid (valp) result was obtained on a patient sample on a dimension exl 200 integrated chemistry system.The initial result was not reported to the physician(s).The sample was repeated eleven times on an original dimension exl 200 integrated chemistry system.The first four repeat results were similarly depressed and were considered erroneous.The remaining seven repeat results recovered higher than the initial and first four repeat results.The seven repeat results were considered correct and the repeat result of "60.15 ug/ml" was reported to the physician(s).There is no known reports of patient intervention or adverse health consequences due to the falsely depressed valp results.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc) and reported that a falsely depressed valproic acid (valp) result was obtained on a patient sample on the dimension exl 200 integrated chemistry system.Quality control (qc) and calibration were acceptable on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse replaced the photometer belt and assay of photometer belt tension, performed arm alignment and system check which recovered acceptably.The cause of the falsely depressed valp results is unknown.Siemens is evaluating the event.
Additional Manufacturer Narrative
Siemens filed initial mdr 2517506-2024-00276 on 24-oct-2024.Additional information (29-nov-2024): siemens reviewed the instrument data and determined that there were no issues with the reagent as quality control (qc) recovered within acceptable ranges.Siemens evaluated the event and determined that the photometric belt issue, which was addressed with the service activities mentioned in the initial report, potentially contributed to the falsely depressed valp results.The investigation conclusions 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: mekala g ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 840457474
• MDR Report Key: 20520884
• Report Number: 2517506-2024-00276
• Device Sequence Number: 15383085
• 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): 12/09/2024

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: 10/10/2024
• Supplement Date Received by Manufacturer: 11/29/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2020
• 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