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

Model Number 10445163

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

Mdrs 2517506-2020-00168, 2517506-2020-00169, 2517506-2020-00170, and 2517506-2020-00171 were filed for the same event.The customer contacted the siemens customer care center (ccc) and reported that discordant, falsely depressed carbon dioxide (co2) patient results were obtained on one patient's samples on the dimension vista 500 system.Siemens is investigating the event.

Event Description

Discordant falsely depressed carbon dioxide (co2) results were obtained on one patient's samples on the dimension vista 500 system.The discordant results were reported to the physician(s).The same samples were reprocessed on the same day on a non-siemens instrument and higher results, regarded as correct, were obtained.Corrected results were reported from the non-siemens instrument.There are no known reports of patient intervention or adverse health consequences due to the discordant falsely depressed co2 results.

Manufacturer Narrative

Mdrs 2517506-2020-00168, 2517506-2020-00169, 2517506-2020-00170, and 2517506-2020-00171 were filed on 04-jun-2020 for the same event.Additional information (22-jun-2020): siemens headquarters support center (hsc) completed their investigation of the discordant, falsely depressed carbon dioxide (co2) patient results obtained on one patient's samples on the dimension vista 500 system.Quality control was within range without evidence of imprecision or outliers.The customer has not reported discordant results samples from other patients suggesting the issue is sample specific.Methodology differences between the dimension vista methodology and the alternate non-siemens methodology cannot be ruled out.The cause is unknown.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Mdr supplements 2517506-2020-00168 supplement 1, 2517506-2020-00169 supplement 1, 2517506-2020-00170 supplement 1 and 2517506-2020-00171 supplement 1 were filed for the same event.

• 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
• MDR Report Key: 10121270
• MDR Text Key: 195658601
• Report Number: 2517506-2020-00172
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00842768015625
• UDI-Public: 00842768015625
• Combination Product (y/n): N
• PMA/PMN Number: K061238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/10/2020

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: 12/08/2020
• Device Model Number: 10445163
• Device Catalogue Number: K1137 SMN 10445163
• Device Lot Number: 19343BD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/04/2020
• Supplement Dates Manufacturer Received: 06/22/2020
• Supplement Dates FDA Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1