MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500

Model Number	DIMENSION VISTA 500
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that a falsely depressed carbon dioxide (co2) result was obtained on a patient sample on a dimension vista 500 instrument.Quality control (qc) recovered within range prior to running patient sample on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse entered diagnostics mode, ran a mix test, replaced and auto aligned the sample 1 (s1) mixer assembly, primed all probes (b)(4) times, and reset the instrument.The cse also ran qc and a quick check, which passed.The cause of the falsely depressed co2 result is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that a falsely depressed carbon dioxide (co2) result was obtained on a patient sample on a dimension vista 500 instrument.The erroneous result was not reported to the physician(s).The sample was repeated on the original dimension vista 500 instrument.The repeat result recovered higher than the erroneous result.The repeat result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed co2 result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2517506-2024-00227 on 16-sep-2024.Additional information (17-sep-2024): siemens reviewed the instrument data and determined that calibration was acceptable.Siemens evaluated the event and determined that the sample mixer potentially contributed to the falsely depressed carbon dioxide (co2) result, which was resolved by replacing and aligning the sample 1 (s1) mixer assembly by the customer service engineer (cse) as described in the initial report.The investigation conclusions code of section h6 was updated to reflect the additional information.The instrument was performing within specifications.No further evaluation of this device is required.

• Brand Name: DIMENSION VISTA 500
• Common Device Name: DIMENSION VISTA 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 101 silvermine road; registration number: 1226181; brookfield CT 06804
• Manufacturer Contact: mekala g ; pritech park sez, block 11,; sarjapur outer ring road,; bengaluru, karnataka, NY 56010-3 ; IN 560103 ; 9086354191
• MDR Report Key: 20231679
• Report Number: 2517506-2024-00227
• Device Sequence Number: 21060894
• Product Code: JJE
• UDI-Device Identifier: 00630414593517
• UDI-Public: (01)00630414593517
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 10/08/2024

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 Model Number: DIMENSION VISTA 500
• Device Catalogue Number: 10488217
• 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: 08/28/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female