Model Number 10445163 |
Device Problem
Low Test Results (2458)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 05/10/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Mdrs 2517506-2020-00168, 2517506-2020-00170, 2517506-2020-00171, and 2517506-2020-00172 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, 2517506-2020-00170, 2517506-2020-00171, and 2517506-2020-00172 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, 2517506-2020-00170 supplement 1, 2517506-2020-00171 supplement 1 and 2517506-2020-00172 supplement 1 were filed for the same event.
|
|
Search Alerts/Recalls
|
|