ELECSYS PROBNP II
Received Jan 4, 2024 · Event occurred Dec 13, 2023
Report 1823260-2024-00033 · MDR key 18445077
Device
Generic name
Natriuretic Peptide Test
Manufacturer
Roche DiagnosticsCatalog number
09315268160
Lot number
ASKU
Product problems
- Low Test Results
- Insufficient Device Problem Information
- Non Reproducible Results
- Low Test Results
- Insufficient Device Problem Information
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE LOT NUMBER AND EXPIRATION DATE OF THE PROBNP REAGENT WERE REQUESTED, BUT NOT PROVIDED. 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 TWO COBAS E 601 MODULE ANALYZERS. IT WAS ASKED, BUT IT IS NOT KNOWN WHICH OF THE TWO ANALYZERS WAS USED FOR EACH MEASUREMENT. THE SAMPLE INITIALLY RESULTED IN A PROBNP VALUE OF < 36 PG/ML WHEN TESTED ON THE FIRST E601 ANALYZER. THE PHYSICIAN QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE SECOND E601 ANALYZER, RESULTING IN A PROBNP VALUE OF 8000 PG/ML. THE REPEAT VALUE WAS DEEMED CORRECT.
Additional Manufacturer Narrative
THE CUSTOMER STATED THEY HAD NO ISSUES WITH CALIBRATIONS AND CONTROLS PASSED. THE FIELD SERVICE ENGINEER COULD NOT DETERMINE ANY ISSUES WITH THE INSTRUMENTS. THE INSTRUMENTS WERE INSPECTED, THE SAMPLE PROBE VOLTAGE WAS CHECKED, AND PRECISION STUDIES WERE PERFORMED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. MEDWATCH FIELDS D1, D2, D4, G1, AND G4 HAVE BEEN UPDATED.