ELECSYS PROBNP II
Received Jul 28, 2025 · Event occurred Jun 12, 2025
Report 1823260-2025-02315 · MDR key 22636442
Device
Generic name
Natriuretic Peptide Test
Manufacturer
Roche DiagnosticsCatalog number
09315268160
Lot number
841698
Product problems
- Low Test Results
- Non Reproducible Results
- Low Test Results
- Non Reproducible Results
Patient
93 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS PROBNP II ON A COBAS E411 RACK ANALYZER. THE SAMPLE INITIALLY RESULTED IN A PROBNP VALUE OF 71.6 PG/ML. A DOCTOR QUESTIONED THE RESULT BECAUSE IT DID NOT MATCH THE PATIENT'S HISTORY. THE SAMPLE WAS REPEATED, RESULTING IN A PROBNP VALUE OF 4898 PG/ML. THE REPEAT VALUE WAS DEEMED CORRECT AND MATCHED THE PATIENT'S HISTORY.
Additional Manufacturer Narrative
NO CALIBRATION INFLUENCE WAS OBSERVED. CONTROLS WERE WITHIN RANGE BEFORE AND AFTER THE EVENT. A GENERAL REAGENT OR ANALYZER ISSUE WAS NOT PRESENT. ISOLATED NON-REPRODUCIBLE RESULTS DO NOT REPRESENT A GENERAL MALFUNCTION OF THE ASSAY. A REVIEW OF ALARM TRACE DATA DID NOT SHOW ANY RELEVANT ALARMS. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.