ELECSYS PROBNP II
Received Apr 2, 2026 · Event occurred Mar 7, 2026
Report 1823260-2026-01240 · MDR key 24767547
Device
Generic name
Natriuretic Peptide Test
Manufacturer
Roche DiagnosticsCatalog number
09315268160
Lot number
ASKU
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE FIELD SERVICE ENGINEER (FSE) REPLACED THE MEASURING CELL AND PERFORMED MECHANICAL CHECKS, PRECISION TESTING, AND CALIBRATION. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS PROBNP II AND ELECSYS TROPONIN T GEN 5 STAT RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 411 ANALYZER (DISK SYSTEM). THIS MEDWATCH WILL COVER BNP. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TROPONIN RESULTS. THE INITIAL TROPONIN RESULT WAS 45.6 PG/ML AND THE INITIAL BNP RESULT WAS 322 NG/L. THE DOCTOR QUESTIONED THE RESULTS WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE REPEAT TROPONIN RESULT WAS 70.6 PG/ML AND THE REPEAT BNP RESULT WAS 598 NG/L. THE REPEAT RESULTS WERE DEEMED CORRECT.