ELECSYS PROBNP II STAT IMMUNOASSAY
Received May 19, 2023 · Event occurred Mar 8, 2023
Report 1823260-2023-01686 · MDR key 16960905
Device
Generic name
Natriuretic Peptide Test
Manufacturer
Roche DiagnosticsModel number
NACatalog number
08836736190
Lot number
651829
Product problems
- False Negative Result
- Low Test Results
- False Negative Result
- Low Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE PROBNP G2 ELECSYS RESULT FROM COBAS E602 ANALYZER SERIAL NUMBER 17D7-03. THE INITIAL RESULT WAS <5PG/ML AND WAS REPORTED OUTSIDE THE LABORATORY AS <10 PG/ML. AS THE RESULT WAS CONSIDERED DISCREPANT WITH BNP RESULTS OF 397 AND 395 PG/ML, THE DOCTOR SUSPECTED THE PATIENT HAS SOME MUTATED NT-PROBNP.
Additional Manufacturer Narrative
THE SAMPLE WAS SUBMITTED FOR PRELIMINARY INVESTIGATION AND THE RESULTS WERE: SERUM- NT-PROBNP: <10 PG/ML. PLASMA- (EDTA-2K) NT-PROBNP: <10 PG/ML. PLASMA- (EDTA-2NA) NT-PROBNP: <10 PG/ML. THE INVESTIGATION IS ONGOING. H3 OTHER TEXT.
Additional Manufacturer Narrative
THE INVESTIGATION CONFIRMED THE CUSTOMER'S RESULTS. TWO POINT MUTATIONS (R72H AND E69D) IN THE EPITOPE OF THE DETECTION ANTIBODY WERE FOUND IN THE PATIENT SAMPLE. PER PRODUCT LABELING FOR THE ASSAY "IN EXTREMELY RARE CASES (GLOBAL INCIDENCE: < 1 IN 10 MILLION), PATIENTS MAY SHOW DISCREPANT RESULTS WHEN TESTED WITH THE ASSAY KIT (VALUES < LOWER DETECTION LIMIT) DUE TO A NT-PROBNP GENETIC VARIANT."