MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; DIMENSION® QUIKLYTE® INTEGRATED MULTISENSOR

Catalog Number	S600 SMN 10445058
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A discordant falsely elevated sodium (na) patient sample result was obtained on a dimension® exl¿ 200 integrated chemistry system.The falsely elevated patient result was not reported to the physician(s).The same sample was reprocessed on the same dimension® exl¿ 200 integrated chemistry system.The lower reprocessed result obtained was considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated sodium (na) result.
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a falsely elevated sodium (na) patient result obtained on a dimension® exl¿ 200 integrated chemistry system.Siemens is investigating the event.
Additional Manufacturer Narrative
Additional information (17-apr-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc evaluated the information provided by the customer and the instrument data logs.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse inspected the integrated multisensor technology (imt) and found that the cable in the imt tower was worn out and also there was an error in detecting the flush.The cse performed maintenance that was part of standard troubleshooting including replacement of imt tubing, and the flush pump and then primed and conditioned the imt.Hsc notes that the issue was resolved after replacing the cable but also mentions that they cannot rule out sample integrity or a sample handling issue as only one patient sample was reported as discordant on the day the issue occurred.Quality control recovered within the customer's expected ranges and review of the instrument data files shows that the dilution check factor was within the normal range when the issue occurred indicating that there was no issue with the imt sensor or the dimension exl 200 integrated chemistry system.The cause of the event is unknown.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2517506-2024-00116 was filed on 02-apr-2024.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® QUIKLYTE® INTEGRATED MULTISENSOR
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 19020746
• Report Number: 2517506-2024-00116
• Device Sequence Number: 8156657
• Product Code: JGS
• UDI-Device Identifier: 00842768014291
• UDI-Public: 00842768014291
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2024

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 Expiration Date: 07/06/2024
• Device Catalogue Number: S600 SMN 10445058
• Device Lot Number: 4AD802
• 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: 03/19/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown