ELECSYS BRAHMS PCT
Received Jan 2, 2026 · Event occurred Dec 5, 2025
Report 1823260-2026-00002 · MDR key 23942961
Device
Generic name
Procalcitonin Assay
Manufacturer
Roche DiagnosticsCatalog number
08828644190
Lot number
864044
Product problems
- Incorrect Measurement
- High Test Results
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS 6000 E601 MODULE SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS BRAHMS PCT RESULTS FROM THE COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS >100 NG/ML. THE PHYSICIAN REQUESTED MANUAL DILUTION, AND THE CUSTOMER PERFORMED A 1:4 MANUAL DILUTION. THE RESULT WAS 15 NG/ML (X4=60 NG/ML). THE CUSTOMER PERFORMED ANOTHER 1:2 MANUAL DILUTION OF THE ORIGINAL SAMPLE, PRODUCING A RESULT OF 52 NG/ML. THE CUSTOMER DID NOT KNOW WHICH RESULT WAS CORRECT.
Additional Manufacturer Narrative
THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. A GENERAL REAGENT OR ANALYZER PROBLEM WAS NOT PRESENT, BECAUSE THE QC PRIOR TO THE EVENT WAS WITHIN RANGES.