MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA® CO2 CARBON DIOXIDE FLEX® REAGENT CARTRIDGE

Catalog Number	K1137 SMN 10445163
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens customer care center (ccc) and reported that discordant, falsely depressed carbon dioxide (co2) results were obtained on the dimension vista 1500 system on one patient.Siemens headquarters support center (hsc) has completed their evaluation of the event and the information provided.The cause is unknown.Hsc review of the instrument data for this event indicates qc is within range with no evidence of outliers to suggest an instrument problem.Hsc review of water processing module (wpm) properties indicated no water quality issues were observed that could contribute to a falsely low co2 result.No consumable product problem has been identified.The device is operating per specifications.No further evaluation of the device is required.
Event or Problem Description
A discordant, falsely depressed carbon dioxide (co2) result was obtained on a patient venous sample on two dimension vista 1500 systems.The results were reported to the physician who questioned the result.An arterial blood sample from the same patient was tested by an alternate non-siemens methodology (blood gas analyzer) and a higher result was obtained.The original venous sample was repeated on the alternate methodology and the higher result was obtained.A corrected report was issued.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely depressed co2 result.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® CO2 CARBON DIOXIDE FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7469870
• Report Number: 2517506-2018-00262
• Device Sequence Number: 16171496
• Product Code: KHS
• UDI-Device Identifier: 00842768015625
• UDI-Public: 00842768015625
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K061238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2018

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: 08/28/2018
• Device Catalogue Number: K1137 SMN 10445163
• Device Lot Number: 17240BC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1