PROBNP II, N-TERMINAL PRO B-TYPE NATRIURETIC PEPTIDE
Received Jul 26, 2018 · Event occurred May 19, 2018
Report 1823260-2018-02466 · MDR key 7721635
Device
Generic name
Test,natriuretic Peptide
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04842464190
Lot number
31591400
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 CUSTOMER PROVIDED SAMPLE WAS TESTED AND A PROBNP MUTATION COULD BE CONFIRMED. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE CUSTOMER RECEIVED QUESTIONABLE LOW ELECSYS PROBNP II IMMUNOASSAY RESULTS FOR TWO PATIENTS WHICH DID NOT MATCH THE CLINICAL SYMPTOMS OF CHRONIC HEART FAILURE. SAMPLES FROM (B)(6) 2018 AND (B)(6) 2018 HAD A RESULT OF <5.00 PG/ML. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND WERE QUESTIONED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE TYPE OF ROCHE ANALYZER USED WAS REQUESTED BUT WAS NOT PROVIDED. THE SAMPLE FROM (B)(6) 2018 WAS SUBMITTED FOR INVESTIGATION AND THE RESULT FROM A COBAS E 411 IMMUNOASSAY ANALYZER WAS <5.00 PG/ML.
Additional Manufacturer Narrative
IT WAS DETERMINED THE CONFIRMED MUTATION IS EXTREMELY RARE AND SO FAR HAS ONLY FOUND IN JAPANESE POPULATIONS. PRODUCT LABELING FOR THE ASSAY DOCUMENTS THIS LIMITATION.