ELECSYS PROBNP II
Received Sep 30, 2022 · Event occurred Sep 7, 2022
Report 1823260-2022-03000 · MDR key 15512177
Device
Generic name
Test,natriuretic Peptide
Manufacturer
Roche DiagnosticsModel number
NACatalog number
09315268190
Lot number
ASKU
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE PROBNP G2 ELECSYS RESULTS FROM COBAS 8000 - COBAS E 602 MODULE SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 35000 NG/L OR MORE. THE REPEAT RESULT WITH A 1:5 DILUTION WAS 26491 NG/L. THE REPEAT RESULT WITH A 1:10 DILUTION WAS 27258 NG/L. THE REPEAT RESULT UNDILUTED WAS 35000 NG/L OR MORE. THE REPEAT RESULT WITH A 1:2 DILUTION WAS 30167 NG/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. IT WAS FOUND THE SAMPLE DILUENT HAD PASSED THE ONBOARD STABILITY. IT WAS REPLACED AND THE SAMPLE WAS REPEATED WITH SIMILAR RESULTS. NO SPECIFIC DATA WAS PROVIDED.