MalfunctionPRI
ELECSYS BRAHMS PCT
Received Mar 11, 2026 · Event occurred Feb 16, 2026
Report 1823260-2026-00863 · MDR key 24570434
Device
Generic name
Procalcitonin Assay
Manufacturer
Roche DiagnosticsCatalog number
08828679190
Lot number
87572901
Product problems
- Incorrect Measurement
- High Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS BRAHMS PCT RESULT FROM THE COBAS E 801 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 0.69 NG/ML. THE REPEAT RESULT WAS 0.05 NG/ML, ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT WAS DEEMED TO BE CORRECT. THE SAMPLE WAS REPEATED AFTER THERE WAS A QC FAILURE FOR ELECSYS BRAHMS PCT.