|
Model Number 09H39-01 |
Device Problem
High Test Results (2457)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/01/2021 |
Event Type
malfunction
|
Event Description
|
The customer observed falsely elevated platelet results generated on the cell-dyn emerald for one sample when compared to another method.The following data was provided: (b)(6) emerald result =142, repeat = 100, advia result = 3.No impact to patient management was reported.
|
|
Manufacturer Narrative
|
(b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
|
|
Event Description
|
The customer observed falsely elevated platelet results generated on the cell-dyn emerald when compared to another method.The following data was provided: sid (b)(6): platelet: emerald =142, repeat = 100, advia = 3.No impact to patient management was reported.
|
|
Manufacturer Narrative
|
The field service representative (fsr) performed various maintenance activities and verified that the instrument passed precision twice using controls.However, precision failed on rbc and plt when using a fresh patient sample.The fse replaced the syringe body and seal plate and performed flushing and backwash.After the service, precision with the blood passed.Quality control (qc) was performed, and all results were within range.The cell dyn emerald analyzer was operating properly for a while, but the issue returned.The cell dyn emerald analyzer generated plt results that were different compared to the other instruments.The instrument maintenance record (event log) was not available for a review.Per customer¿s request, the instrument was removed from the site and no further investigation could be performed.A review of tracking and trending of the cell dyn emerald did not identify any trends associated with the complaint issue.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the cell dyn emerald for serial 5793 was identified.Section g1 has been updated to current contact information.
|
|
Search Alerts/Recalls
|
|
|