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

Model Number	10445163
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) and reported that discordant, falsely elevated carbon dioxide (co2) results were obtained on a dimension vista 1500 system.Siemens healthcare diagnostics headquarters support center (hsc) has reviewed the information provided and the instrument data.Hsc concluded that there is no assay or system issue.Review of the co2 calibrations found the calibrations performed on the date of the event had elevated signal responses and co calibration coefficients which directly relate to poor water.Quality control recovered within range after recalibration.There is no evidence of a product non-conformance.The customer is fully operational.The cause of the event is unknown.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
Discordant, falsely elevated carbon dioxide (co2) results were obtained on patient samples on a dimension vista 1500 system.The discordant results were reported to the physician(s).The same samples were reprocessed on the same instrument on the same date and lower results were obtained, considered correct and reported.Corrected reports were issued there are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated co2 results.

• 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
• MDR Report Key: 10479845
• Report Number: 2517506-2020-00269
• Device Sequence Number: 14111226
• Product Code: KHS
• UDI-Device Identifier: 00842768015625
• UDI-Public: 00842768015625
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2020

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: 03/24/2021
• Device Model Number: 10445163
• Device Catalogue Number: K1137 SMN 10445163
• Device Lot Number: 20084BB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1