ELECSYS PROBNP II IMMUNOASSAY
Received May 19, 2020 · Event occurred Apr 30, 2020
Report 1823260-2020-01257 · MDR key 10069827
Device
Generic name
Test,natriuretic Peptide
Manufacturer
Roche DiagnosticsModel number
NACatalog number
07027664190
Lot number
454331
Product problems
- Low Test Results
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE PATIENT SAMPLE COULD NOT BE PROVIDED FOR INVESTIGATION. THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS PROBNP II IMMUNOASSAY ON A COBAS 8000 E 801 MODULE. THE VALUES OBTAINED WITH THE PROBNP ASSAY DO NOT COMPARE TO A VALUE OBTAINED WITH A BNP ASSAY FROM AN UNKNOWN MANUFACTURER. THE SAMPLE IS SUSPECTED TO CONTAIN AN INTERFERENT TO A COMPONENT OF THE PROBNP ASSAY. THE VALUE FROM THE PROBNP ASSAY WAS REPORTED OUTSIDE OF THE LABORATORY. WHEN TESTED WITH THE ELECSYS PROBNP ASSAY ON THE E 801 ANALYZER, THE RESULT WAS < 5 PG/ML. THE SAMPLE WAS TESTED WITH A BNP ASSAY FROM AN UNKNOWN MANUFACTURER, RESULTING WITH A VALUE OF 565 PG/ML. THE SAMPLE WAS REPEATED WITH THE ELECSYS PROBNP ASSAY ON THE E 801 ANALYZER, RESULTING WITH A VALUE OF < 5 PG/ML. THE E 801 ANALYZER SERIAL NUMBER IS (B)(4).