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

Catalog Number	S600 SMN 10445058
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding the erroneously depressed sodium (na) results obtained on two (2) patient samples on a dimension® exl¿ 200 integrated chemistry system.Siemens is investigating the event.
Event or Problem Description
The customer reported to siemens that they obtained erroneously depressed sodium (na) results for two (2) patient samples on a dimension® exl¿ 200 integrated chemistry system.For sample (b)(6) the erroneous results were not reported to the physician.The same sample was reprocessed on the original dimension® exl¿ 200 integrated chemistry system and the erroneous result was reproduced.Then the same sample was reprocessed on an alternate dimension® exl¿ 200 integrated chemistry system and a higher result was obtained.The higher result obtained was considered correct and reported to the physician.For sample (b)(6) the erroneous results were not reported to the physician.The same sample was reprocessed in duplicate on the original dimension® exl¿ 200 integrated chemistry system.The reprocessed results were lower than the initial result and considered erroneous.The initial result obtained on an alternate dimension® exl¿ 200 integrated chemistry system matched the patient¿s history, considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed sodium (na) results.
Additional Manufacturer Narrative
Additional information (16-may-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.Quality control recovered within the customer's expected ranges and no issues were reported with other patient samples.The issue was resolved after performing the routine integrated multisensor technology (imt) maintenance and replacing the sensor.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 2517506-2024-00139 was filed on 06-may-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: 19247129
• Report Number: 2517506-2024-00139
• Device Sequence Number: 6396973
• Product Code: JGS
• UDI-Device Identifier: 00842768014291
• UDI-Public: 00842768014291
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 06/06/2024

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: 07/20/2024
• Device Catalogue Number: S600 SMN 10445058
• Device Lot Number: 4AD803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2024
• 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