ELECSYS PROBNP II
Received Jan 9, 2025 · Event occurred Dec 19, 2024
Report 1823260-2025-00074 · MDR key 21114921
Device
Generic name
Natriuretic Peptide Test
Manufacturer
Roche DiagnosticsCatalog number
09315284190
Lot number
83462703
Product problems
- Low Test Results
- Non Reproducible Results
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CALIBRATION AND QC WERE ACCEPTABLE. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE ALARM TRACE DATA. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
Additional Manufacturer Narrative
THE E801 ANALYZER SERIAL NUMBER WAS (B)(6) .
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS PROBNP II (PROBNP II) ON A COBAS E 801 ANALYTICAL UNIT. NOTE: THE UNIT OF MEASURE WAS NOT PROVIDED. THE INITIAL RESULT WAS 178. THE REPEAT RESULT WAS 3376.