Model Number C503 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/07/2023 |
Event Type
malfunction
|
Event Description
|
The initial reporter complained of discrepant results for 1 patient sample tested for iron gen.2 (iron2) on a cobas pro c 503 analytical unit.The initial result was 27.5 ug/dl with a data flag.The repeat result was 64.9 ug/dl with a data flag.The sample was repeated twice on a different c503 analyzer with results of 26.0 ug/dl with a data flag and 26.8 ug/dl with a data flag.The sample was repeated twice on the c503 analyzer in question with results of 28.7 ug/dl with a data flag and 27.4 ug/dl with a data flag.The initial result of 27.5 ug/dl was believed to be correct.
|
|
Manufacturer Narrative
|
The iron2 reagent lot number was 71146501 with an expiration date of 29-feb-2024.The field service engineer (fse) visually inspected the sample with no abnormalities.Precision testing was performed with the sample as well as a serum qc pool.All results correlated with the original result of 27.5 ug/dl.A cause for the event was not identified.Instrument performance was verified and the issue appears to be resolved at the customer site.The investigation did not identify a product problem.The cause of the event could not be determined.
|
|
Manufacturer Narrative
|
Section d, device identification was updated.Relevant fields of sections d and g were updated.The c503 analyzer serial number was (b)(6).Calibration was last performed on 01-jul-2023 with acceptable results.Qc was acceptable.There is no indication of a reagent or instrument performance issue.The customer used a centrifugation speed of 2160 revolutions per minute (rpm) for 5.5 minutes.This centrifugation time may be too short and the speed may be too slow based on the sample tubes the customer uses.
|
|
Search Alerts/Recalls
|