Catalog Number 01L75-26 |
Device Problem
High Test Results (2457)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
|
|
Event Description
|
The customer observed falsely elevated architect cyclosporine results for 2 pediatric patients.The patients are a (b)(6) year old with architect cyclosporine measurements every 2-3 weeks.The results usually are around 100 ng/ml but have been measuring high around 130 ng/ml, 150 ng/ml, and 170ng/ml since (b)(6) 2019.No impact to patient management was reported.
|
|
Manufacturer Narrative
|
A review of tickets was performed for architect cyclosporine reagent lot number 01053m800.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.Accuracy testing was performed by using internal cyclosporine panels and were tested using retained kits of the likely cause materials.Acceptance criteria were met, which indicates acceptable product performance.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the architect cyclosporine reagent for lot number 01053m800 was identified.
|
|
Search Alerts/Recalls
|