Catalog Number 10697306 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 09/27/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
The instrument files were analyzed.The data indicates that there were no calibration errors, sensor perturbances or fluidic errors at the time of the two results in question.The cause for the discordant results is unknown.
|
|
Event Description
|
The customer reported discordant sodium results from one rp 500 when compared to another rp 500 at the same site.There was no reported injury due to this event.
|
|
Manufacturer Narrative
|
Review of instrument data files do not indicate any performance issues with the sensors around the time the discordant samples were reported.The data suggests that the sample may have become contaminated by salt from around the sample port/luer area, which may have contributed to the discordant results.Because the cartridge was not returned for evaluation, final root cause for the discordant sample cannot be determined.
|
|
Search Alerts/Recalls
|