MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA; DIMENSION VISTA V-LYTE® INTEGRATED MULTISENSOR NA+ K+ CL-

Catalog Number	SMN 10484429
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding discordant elevated sodium (na) results on patient samples on a dimension vista 1500 intelligent lab system.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the instrument data files and the information provided by the customer.Quality control (qc) and calibration recovery were within the customer¿s expected ranges.Hsc reviewed integrated multisensor technology (imt) analyzer data and observed dilution check factor, air values of standard (std) a and std b and pump rate were within the normal range on the day of event and observed no errors related to imt.The customer is operational after replacing the imt sensor which was a part of standard troubleshooting.The cause of the event is unknown.The customer is operational.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
The customer reported to siemens they obtained discordant elevated sodium (na) results on patient samples on a dimension vista 1500 intelligent lab system.The patient results were reported to the physician and were questioned.It is unknown if the samples were repeated and corrected reports were issued.The customer did not provide the patient data.There are no known reports of patient intervention or adverse health consequences due to the elevated sodium (na) results.

• Brand Name: DIMENSION VISTA
• Common Device Name: DIMENSION VISTA V-LYTE® INTEGRATED MULTISENSOR NA+ K+ CL-
• 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: mekala g ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 840457474
• MDR Report Key: 20415962
• Report Number: 2517506-2024-00269
• Device Sequence Number: 20932824
• Product Code: JGS
• UDI-Device Identifier: 00842768030413
• UDI-Public: (01)00842768030413(10)4ED812(17)241102
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051087
• 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
• Report Date (Section B): 10/10/2024

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: 11/02/2024
• Device Catalogue Number: SMN 10484429
• Device Lot Number: 4ED812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 10/10/2024
• 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