ELECSYS PROBNP II
Received Sep 18, 2025 · Event occurred Aug 29, 2025
Report 1823260-2025-03133 · MDR key 23087758
Device
Generic name
Test,natriuretic Peptide
Manufacturer
Roche DiagnosticsCatalog number
04842464190
Lot number
ASKU
Product problems
- High Test Results
- High Test Results
Patient
16 MO · Unknown
- 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
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS PROBNP II RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS 33452 PG/ML. TWO WEEKS LATER, THE CUSTOMER THAWED A FROZEN SAMPLE FROM THE SAME COLLECTION TO RETEST IT FOR VALIDATION PURPOSES AND THE RESULT WAS 24714 PG/ML. THE EXACT DATE OF RETESTING WAS NOT PROVIDED.
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.