Catalog Number 03003523001 |
Device Problem
High Test Results (2457)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 12/13/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
This event occurred in (b)(6).
|
|
Event Description
|
The initial reporter stated they received discrepant high results for one patient sample tested with the chloride electrode on the cobas integra 400 plus.Samples collected from this same patient will always recover high chloride values when tested on the integra 400 plus.Plausible values are measured on a cobas 6000 c (501) module.No incorrect chloride values were reported outside of the laboratory.The sample initially resulted with a chloride value of 224.8 mmol/l on the integra 400 plus analyzer.The sample was repeated 22 more times on the integra 400 plus and each time it resulted with a value of > 250.0 mmol/l accompanied by a data flag.The sample was repeated on a c 501 analyzer, resulting with a plausible value of 104.5 mmol/l.The sample was repeated eleven more times on the integra 400 plus on (b)(6) 2019, each time resulting with a value of > 250.0 mmol/l accompanied by a data flag.The integra 400 plus analyzer serial number is (b)(4).
|
|
Manufacturer Narrative
|
The investigation could not identify a product problem.The cause of the event could not be determined.Upon investigation of the instrument's database, the chloride electrode was properly calibrated and controls were within range.
|
|
Search Alerts/Recalls
|