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

Model Number 10445163

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2020

Event Type  malfunction  

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 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
• Type of Device: DIMENSION VISTA® CO2 CARBON DIOXIDE FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark, de
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark, de
• Manufacturer Contact: james morgera ; 500 gbc drive; po box 6101; newark, de ; 6318356
• MDR Report Key: 10479845
• MDR Text Key: 205366725
• Report Number: 2517506-2020-00269
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00842768015625
• UDI-Public: 00842768015625
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 09/01/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/24/2020
• 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