MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL 200

Model Number	DIMENSION EXL 200
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens customer care center (ccc) and reported a falsely depressed enzymatic creatinine (ezcr) result that was obtained on one patient sample on a dimension exl 200 instrument.Quality control (qc) and calibration were valid at the time of the event.The cause of the falsely depressed ezcr result is unknown.
Event or Problem Description
A falsely depressed enzymatic creatinine (ezcr) result was obtained on one patient sample on a dimension exl 200 instrument.The erroneous result was reported to the physician(s) and was questioned.The sample was repeated on the same instrument.The repeat result was expected by the doctor and was reported as the correct result.There are no known reports of patient interventions or adverse health consequences due to the falsely depressed ezcr result.
Additional Manufacturer Narrative
Siemens filed the initial mdr (b)(4) on 23-aug-2023.The customer replaced the sample probe.Due to sample clog detect errors observed on the day of the event.Siemens further evaluated the issue and concluded that the sample specific issues such as sample handling or sample integrity potentially contributed to the falsely depressed enzymatic creatinine (ezcr) result.No issues were observed with other patient samples, indicating that the instrument and reagents were performing acceptably.The investigation findings code in section was updated based on the additional information.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: DIMENSION EXL 200
• Common Device Name: DIMENSION EXL 200
• 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: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 17604390
• Report Number: 2517506-2023-00181
• Device Sequence Number: 6283960
• Product Code: JJE
• UDI-Device Identifier: 00842768037214
• UDI-Public: 00842768037214
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K073604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• 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): 08/25/2023

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
• Device Catalogue Number: 10636928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2014
• 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 Age: 73 YR
• Patient Sex: Female