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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that dimension exl 200 enzymatic creatinine discordant results were obtained for eleven patients, and that results were reported to the physician(s).The customer repeated the same samples on an alternate dimension exl analyzer and noted that the repeat results were considered correct.The customer issued corrected reports.Siemens dispatched a customer service engineer (cse) to the customer site.The cse noted no malfunction, and proactive services were performed, including replacing the sample and reagent (r1 and r2) probes and sample transducer.The waste tubing was adjusted, alignments were verified, and no issue was noted.The dimension exl 200 was operating as specified.Siemens is investigating the event.
Event or Problem Description
The customer reported that dimension exl 200 enzymatic creatinine discordant results were obtained for eleven patients, and that results were reported to the physician(s).The customer repeated the same samples on an alternate dimension exl analyzer and noted that the repeat results were considered correct.The customer issued corrected reports.There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2517506-2024-00271 on 14-oct-2024.Additional information (28-oct-2024): siemens reviewed the quality control (qc) data and showed that qc was recovering intermittently low for both level 1 and level 3 and calibration data was acceptable for the assay.A siemens customer service engineer (cse) visited the site, performed services and resolved the issue.The customer ran qc, and results were within the specified limits.The potential cause of the enzymatic creatinine discordant results was due to failed probes (sample/reagent) and sample mixer.The dimension exl 200 analyzer is performing as specified, and no further evaluation of this analyzer is required.Siemens updated section h6 (investigation conclusions) to reflect the additional information.

• 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.; 101 silvermine road; registration #: 1226181; brookfield CT 06804
• Manufacturer Contact: rolando hualpa ; 511 benedict ave.; tarrytown, NY 10591 ; 9143485874
• MDR Report Key: 20446035
• Report Number: 2517506-2024-00271
• Device Sequence Number: 8026164
• 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): 11/21/2024

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: 10/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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