ELECSYS PROBNP II
Received Mar 26, 2026 · Event occurred Mar 3, 2026
Report 1823260-2026-01108 · MDR key 24701955
Device
Generic name
Natriuretic Peptide Test
Manufacturer
Roche DiagnosticsCatalog number
09315268160
Lot number
880994
Product problems
- Low Test Results
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS PROBNP II RESULTS FOR 2 PATIENT SAMPLES ON A COBAS E 411 ANALYZER (DISK SYSTEM). ON (B)(6) 2026, FOR SAMPLE 1, THE INITIAL RESULT WAS 502.9 PG/ML. THE DOCTOR QUESTIONED THE RESULT WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE NEXT DAY, THE SAMPLE WAS REPEATED AND THE RESULT WAS 5175 PG/ML. THE SAMPLE WAS ALSO REPEATED ON ANOTHER ANALYZER AND THE RESULT WAS 5203 PG/ML. THE REPEAT RESULTS WAS DEEMED CORRECT. FOR SAMPLE 2, THE INITIAL RESULT WAS <36 PG/ML WITH FLAG. THE REPEAT RESULT WAS 2191 PG/ML.
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE FIELD SERVICE ENGINEER (FSE) CHECKED THE SAMPLE AND REAGENT PROBES, REPLACED PINCH TUBING, PERFORMED LIQUID FLOW CLEANING, AND PERFORMED A POOLED SAMPLE PRECISION TEST SUCCESSFULLY. THE INVESTIGATION IS ONGOING.