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

Model Number	N/A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens that they obtained erroneous sodium (na) results on multiple patient samples on a dimension vista 500 system, resulting in negative anion gaps.The erroneous results were not reported to the physician(s).The same samples were reprocessed on an alternate dimension vista 500 system.The reprocessed results from an alternate dimension vista 500 system matched the patient¿s clinical picture and were reported as the correct results to the physician(s), resulting in positive anion gaps.There are no known reports of patient intervention or adverse health consequences due to the erroneous sodium (na) results.
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneous sodium (na) results obtained on multiple patient samples on a dimension vista 500 system, resulting in negative anion gaps.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the available instrument data files and the information provided by the customer.A review of the instrument data indicated an integrated multisensor technology (imt) drift error on the event date.Calibration was acceptable.Quality control (qc) recovery was within the customer¿s expected ranges, indicating that the na assay was performing acceptably.Hsc indicated that the issue is consistent with excessive drift that occurred after a clean cycle, as the sensor did not recover from residual bleach based on the occurrence of an imt drift error.The system automatically recovered without any service actions.The cause of the event is unknown.The customer is operational.The device is performing within specifications.No further evaluation is required.

• 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: 20619991
• Report Number: 2517506-2024-00281
• Device Sequence Number: 8792669
• Product Code: JGS
• UDI-Device Identifier: 00842768030413
• UDI-Public: (01)00842768030413(10)4ED812(17)241102
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/06/2024

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: 11/02/2024
• Device Model Number: N/A
• Device Catalogue Number: K800A SMN 10484429
• Device Lot Number: 4ED812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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