Catalog Number 07027290190 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Output Problem (3005); Non Reproducible Results (4029)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/08/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
The cobas pure instrument serial numbers were(b)(6) and (b)(6).The customer began to use reagent lot 703979 on (b)(6) 2023.On (b)(6) 2023 qc was outside of the acceptable range.The customer recalibrated but still had issues.The customer replaced the reagent pack and calibrated it.Qc was acceptable.After one week, qc was outside of the acceptable range again.Recalibrating did not resolve the issue.Monthly maintenance was performed on (b)(6) 2023.The investigation is ongoing.
|
|
Event Description
|
The initial reporter complained of qc issues for elecsys folate iii (folate iii) on both of their cobas pure instruments.The customer performed a patient comparison with a different site and discrepant results were identified for 1 patient sample.It is not known if the comparison data was generated for troubleshooting purposes only or if it was used for diagnostic purposes.On (b)(6) 2023 the result from the other site using 703979 was 23 nmol/l.On (b)(6) 2023 the result using reagent lot 703979 on the customer¿s instrument was 17.5 nmol/l.On (b)(6) 2023 the result using reagent lot 728047 on the customer¿s instrument was 18.2 nmol/l.
|
|
Manufacturer Narrative
|
The medical device problem codes were updated.The high result from the different site using reagent lot 703979 is believed to be incorrect.The customer's calibration data for reagent lot 703979 was slightly lower than expected.The customer's calibration data for reagent lot 728047 was acceptable.The sample was measured on different days at different sites.Sample stability per product labeling: "stable for 2 hours at 20-25 °c, 48 hours at 2-8 °c, 28 days at -20 °c (± 5 °c).Freeze only once.Protect from light.Store the samples at 2-8 °c if they cannot be measured immediately." based on the limited information provided, the cause of the event could not be determined.The investigation did not identify a product problem.
|
|
Search Alerts/Recalls
|