ELECSYS PROBNP II IMMUNOASSAY
Received Nov 2, 2020 · Event occurred May 1, 2019
Report 1823260-2020-02729 · MDR key 10770233
Device
Generic name
Test,natriuretic Peptide
Manufacturer
Roche DiagnosticsModel number
NACatalog number
07027664190
Lot number
ASKU
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 PATIENT SAMPLE WAS INVESTIGATED AND THE CUSTOMER¿S NT-PROBNP RESULT WAS CONFIRMED. TWO POINT MUTATIONS (R72H AND E69D) IN THE EPITOPE OF THE DETECTION ANTIBODY WERE REPORTED. MEASUREMENTS WITH 2 ELECSYS PROBNP II SALES LOT KITS SUPPLEMENTED WITH ADDITIONAL DETECTION ANTIBODIES FOR THESE MUTATIONS SHOWED THAT THE NT-PROBNP VALUE OF THE COMPLAINT SAMPLE IS NOT FALSELY LOWERED DUE TO R72H OR E69D MUTATION. THIS RESULT INDICATES THAT THE NT-PROBNP VALUE MEASURED WITH THE PROBNP II ASSAY IS CORRECT AND NEEDS TO BE DISCUSSED FROM A CLINICAL POINT OF VIEW. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS PROBNP II IMMUNOASSAY RESULTS FOR 2 PATIENT SAMPLES ON A COBAS E 801 MODULE. THE SERIAL NUMBER FOR THE ANALYZER USED AT THE CUSTOMER SITE WAS REQUESTED, BUT NOT PROVIDED. (B)(6). THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.