ELECSYS PROBNP II IMMUNOASSAY
Received Apr 25, 2019
Report 1823260-2019-90093 · MDR key 8549748
Device
Generic name
Test,natriuretic Peptide
Manufacturer
Roche DiagnosticsModel number
PROBNP G2Lot number
30272403
Product problems
- Low Test Results
- Low Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION FOR THE 1 EVENT DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE WERE NO FOLLOW UP/CORRECTIVE ACTIONS FOR THE 1 EVENT. NO DEVICES WERE RETURNED. THIS DEVICE IS NOT LABELED FOR SINGLE USE AND IS NOT REPROCESSED OR REUSED.
Description of Event or Problem
THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. AN ERRONEOUS LOW RESULT WAS GENERATED BY A COBAS E 411 IMMUNOASSAY ANALYZER WHEN COMPARED TO THE RESULT FROM A DIFFERENT METHOD. THE EVENT INVOLVED 1 PATIENT WITH LOW ELECSYS PROBNP II IMMUNOASSAY RESULT.