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

Model Number	N/A
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
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously elevated sodium (na) patient result obtained on a dimension exl 200 system.Siemens is investigating the event.
Event or Problem Description
The customer reported that an erroneously elevated sodium (na) patient result was obtained on a dimension exl 200 system.The erroneously elevated patient result was not reported to the physician.The same sample was reprocessed on the original dimension exl 200 system.A lower result obtained, matched patient's history and was considered correct and reported.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated sodium (na) patient result.
Additional Manufacturer Narrative
Additional information (24-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 files.Quality control (qc) recovered within customer's acceptable ranges.Assessment of instrument performance included a review of dilution check factor which was slightly less than the normal range, however, within acceptable limit.The cause of the event is unknown, however, hsc cannot rule out sample integrity issues.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 2517506-2024-00118 was filed on 11-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: 19089368
• Report Number: 2517506-2024-00118
• Device Sequence Number: 7651067
• 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 Model Number: N/A
• Device Catalogue Number: 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: 04/24/2024
• Initial Report FDA Received Date: 04/11/2024
• 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