MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500

Model Number DIMENSION VISTA 1500

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2024

Event Type  malfunction  

Event Description

The customer reported that falsely depressed carbon dioxide (co2) results were obtained on four patient samples on a dimension vista 1500 instrument.The initial results were reported to the physician(s).The samples were repeated on an alternate dimension vista 1500 instrument.The repeat results recovered higher than the initial results and matched the patients' history.The repeat results were considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed co2 results.

Manufacturer Narrative

A united states (us) customer contacted a siemens customer care center (ccc) and reported that falsely depressed carbon dioxide (co2) results were obtained on four patient samples on a dimension vista 1500 instrument.Quality control (qc) was acceptable on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse ran service method tests for server 3 (s3) and reagent probe 5 (r5), which recovered acceptably.The cse moved all chemistry tests from server 3 to a different server on the instrument and the customer requested for the tests to remain on the new server.Qc and calibration were run, which recovered acceptably.The cause of the falsely depressed co2 results is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.

Manufacturer Narrative

Siemens filed initial mdr 2517506-2024-00091 on 06-mar-2024.Additional information (13-mar-2024): siemens reviewed the instrument data and ruled out reagent issues as quality control (qc) recovered within acceptable ranges, calibration was acceptable, and no issues were reported with other patient samples.Siemens further evaluated the event and determined that there was no evidence of instrument issues on server 3.Sample handling issues potentially contributed to the falsely depressed carbon dioxide (co2) results.The investigation findings code and investigation conclusions code in section h6 were updated to reflect the additional information.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: DIMENSION VISTA 1500
• Type of Device: DIMENSION VISTA 1500
• 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: christina lam ; 511 benedict ave; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 18852148
• MDR Text Key: 337706573
• Report Number: 2517506-2024-00091
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION VISTA 1500
• Device Catalogue Number: 10444801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1