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

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside the united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a falsely depressed sodium (na) result on a patient sample when processed on a dimension exl system.Quality control (qc) were within the ranges for this assay.Siemens is investigating the event.
Event or Problem Description
A discordant falsely depressed sodium (na) result was obtained on a patient sample processed on a dimension exl system.The falsely depressed result was not reported to the physician(s).The same sample was reprocessed on the original dimension exl system and on an alternate dimension exl system.The reprocessed results were higher compared to the initial result and were considered correct.The higher reprocessed result from the original system was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed sodium (na) result.
Additional Manufacturer Narrative
Additional information (08-mar-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc evaluated the information provided by the customer and the available instrument data logs.Hsc observed that the dilution check factor was within the normal range.Calibration and quality control recovered within the customer's expected ranges.The customer has performed standard troubleshooting on the integrated multisensor technology (imt) system as whole by priming all the imt reagents, checking the tubing condition, aligning imt pump and replaced the imt 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 2517506-2024-00085 was filed on 01-mar-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: 18815218
• Report Number: 2517506-2024-00085
• Device Sequence Number: 8307839
• Product Code: JGS
• UDI-Device Identifier: 00842768014291
• UDI-Public: 00842768014291
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2024

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: 05/04/2024
• Device Model Number: N/A
• Device Catalogue Number: S600 SMN 10445058
• Device Lot Number: 3LD825
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2023
• 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 Age: 62 YR
• Patient Sex: Female