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	11/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A discordant, falsely depressed troponin patient result was generated for one patient on a dimension exl 200 instrument.The initial result was not sent to the physician(s).The same sample was repeated on the same instrument twice.The repeat results were reported, as the correct results, to the physician(s).There were no known reports of patient intervention or adverse health consequence due to this event.
Additional Manufacturer Narrative
An outside of united states (ous) customer reported that a discordant, falsely depressed troponin patient result was generated for one patient on a dimension exl 200 instrument.The employee contacted the siemens customer care center (ccc) and a siemens customer service engineer (cse) was dispatched to the customer's site and inspected the instrument.A visual check of the sample arm and sample tube were performed.They were well centered and not bent, tubing was in good condition, including clot detector and syringe.There were no clot detection errors at the time of the event.All system checks were acceptable.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2517506-2023-00269 on 01-dec-2023.Additional information (12-dec-2023): reagent issues were ruled out as there were no reports of issues with quality controls or other patient samples.Based on the available information, siemens determined short sample or sample integrity issues potentially contributed to the falsely depressed troponin patient result.System is fully operational.No further evaluation of the 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.; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: eric so ; 511 benedict ave.; tarrytown, NY 10591 ; 2012144764
• MDR Report Key: 18248651
• Report Number: 2517506-2023-00269
• Device Sequence Number: 15124763
• Product Code: JJE
• UDI-Device Identifier: 00842768037214
• UDI-Public: 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): 01/07/2024

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
• 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: 11/23/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 01/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 84 YR
• Patient Sex: Female