PROBNP II, N-TERMINAL PRO B-TYPE NATRIURETIC PEPTIDE
Received May 7, 2018 · Event occurred Apr 20, 2018
Report 1823260-2018-01406 · MDR key 7492031
Device
Generic name
Test,natriuretic Peptide
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04842464190
Lot number
29280800
Product problems
- Low Test Results
- Low Test Results
Patient
66 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE CUSTOMER RECEIVED QUESTIONABLE ELECSYS PROBNP II IMMUNOASSAY RESULTS FOR ONE PATIENT. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND WERE BELIEVED TO BE NOT HIGH ENOUGH BY THE DOCTOR SINCE THE PATIENT WAS DIAGNOSED WITH ACUTE CORONARY HEART FAILURE (ACUTE CHF). THE INITIAL RESULT WAS 338 PG/ML AND THE REPEAT RESULT WAS 335.4 PG/ML. AS ANALYTE-SPECIFIC ANTIBODIES OR AN INTERFERENCE WAS SUSPECTED, THE CUSTOMER REPEATED THE SAMPLE WITH DILUTIONS. WITH A 1:2 DILUTION, THE RESULT WAS 324.7 PG/ML. WITH A 1:10 DILUTION, THE RESULT WAS 335.4 PG/ML. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER USED COBAS E 411 IMMUNOASSAY ANALYZER SERIAL NUMBER (B)(4). AS NO SAMPLE COULD BE PROVIDED, FURTHER INVESTIGATION WAS NOT POSSIBLE. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.