ELECSYS PROBNP II
Received Apr 27, 2026 · Event occurred Mar 26, 2026
Report 1823260-2026-01610 · MDR key 24999745
Device
Generic name
Natriuretic Peptide Test
Manufacturer
Roche DiagnosticsCatalog number
09315284214
Lot number
90695102
Product problems
- Low Test Results
- Non Reproducible Results
Patient
86 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS PROBNP II RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. PATIENT 1: THE INITIAL RESULT WAS 23.7 PG/ML THE REPEAT RESULTS WERE 3770 PG/ML, 4366 PG/ML, AND 3822 PG/ML. THE RESULT OF 3770 PG/ML WAS REPORTED OUTSIDE OF THE LABORATORY. PATIENT 2 (B)(6) 2026): THE INITIAL RESULT WAS 7.29 PG/ML. THE REPEAT RESULTS WERE 77.6 NG/ML AND 76.1 NG/ML. THE RESULT OF 77.6 NG/ML WAS REPORTED OUTSIDE OF THE LABORATORY.
Additional Manufacturer Narrative
THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGAITON IS ONGOING.