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 Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information (04-nov-2024): siemens healthcare diagnostics concluded the investigation of the event.Siemens reviewed the instrument data files and the information provided by the customer.Calibration was acceptable.Quality control (qc) recovery was within the customer¿s expected ranges, indicating that the sodium (na) assay was performing acceptably.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse replaced all integrated multisensor (imt) tubings, sample level sense cable, performed successful detection test, verified imt dilution fluidics, and ran imt repeatability test, which passed.Siemens evaluated the event and determined that the sample level sense cable potentially contributed to the erroneous na results.The customer is operational.The instrument is performing according to specifications.No further evaluation of this device is required.Section h6 has been updated to reflect siemens investigation.Initial mdr 2517506-2024-00277 was filed on 25-oct-2024.Correction: sections d1, d2, and d4 have been updated to reflect the instrument details.Section g1 has been updated to reflect the contact office - manufacturing site details of the instrument.Section g4 has been updated to reflect the pma/510(k) number of the instrument.Section h4 has been updated to reflect the device manufacture date for the instrument.Section h8 has been updated to reflect the usage of device for the instrument.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding erroneous sodium (na) results obtained on two (2) patient samples on a dimension exl 200 integrated chemistry system.Siemens is investigating the event.
Event or Problem Description
The customer reported to siemens that they obtained erroneous sodium (na) results on two (2) patient samples on a dimension exl 200 integrated chemistry system.For sample identifier (b)(6), the erroneously depressed sodium (na) result was reported to the physician(s), and the result was questioned.For sample identifier (b)(6), the erroneously depressed result was not reported to the physician(s).The serum samples from the other tubes collected alongside the initially processed plasma samples, as well as the initial plasma samples from the original tubes, were reprocessed on the original dimension exl 200 integrated chemistry system.For sample identifier (b)(6), higher reprocessed results were obtained on both serum and plasma samples and considered correct.A corrected report was issued using the serum sample result.For sample identifier (b)(6), higher reprocessed results were obtained on a serum sample that were considered erroneously elevated and not reported to the physician(s).Also, a higher reprocessed result was obtained on a plasma sample compared to the initial result, considered correct, and reported.There are no known reports of patient intervention or adverse health consequences due to the erroneous sodium (na) results.

• 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 6101
• Manufacturer Contact: mekala g ; pritech park sez, block 11,; sarjapur outer ring road,; karnataka 56010-3 ; IN 560103 ; 840457474
• MDR Report Key: 20531177
• Report Number: 2517506-2024-00277
• Device Sequence Number: 12436769
• Product Code: JJE
• UDI-Device Identifier: 00842768037214
• UDI-Public: (01)00842768037214
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/20/2024

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 Expiration Date: 12/14/2024
• Device Model Number: DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM
• Device Catalogue Number: 10636928
• Device Lot Number: N/A
• 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: 10/16/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2019
• 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