ELECSYS PROBNP II

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS PROBNP II IMMUNOASSAY VER. 2.1 ON A COBAS E 801 ANALYTICAL UNIT (SERIAL NUMBER(B)(4). THE SAMPLE INITIALLY RESULTED IN A PROBNP VALUE OF 18.3 PG/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO MEDICAL PERSONNEL. THE RESULT WAS QUESTIONED SINCE IT DID NOT AGREE WITH THE PATIENT'S CLINICAL PICTURE. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 5299 PG/ML, WHICH WAS DEEMED CORRECT AND MATCHED THE PATIENT'S CLINICAL PICTURE. A SECOND SAMPLE COLLECTED FROM THE PATIENT RESULTED IN A PROBNP VALUE OF > 5000 PG/ML.

Additional Manufacturer Narrative

FACILITY NAME WAS PROVIDED AS "BARRUALDE-GALDAKAOKO ERAKUNDE SANITARIO INTEGRATUA ORGANIZACION SANITARIA INTEGRADA BARRUALDE-GALDAKAO"

Additional Manufacturer Narrative

THE LAST CALIBRATION WAS PERFORMED ON (B)(6) 2022 AND CALIBRATION SIGNALS WERE WITHIN EXPECTATIONS. PER PRODUCT LABELING, RENEWED CALIBRATION IS RECOMMENDED AFTER 12 WEEKS WHEN USING THE SAME REAGENT LOT. CONTROLS WERE WITHIN SPECIFIED RANGES ON THE DAY OF THE EVENT. CALIBRATION AND CONTROLS DO NOT POINT TO A GENERAL REAGENT OR INSTRUMENT PROBLEM. THE SAMPLE CLOTTING TIME WAS SHORTER THAN RECOMMENDED BY THE TUBE MANUFACTURER. UPON REVIEW OF THE ALARM TRACE, AN ABNORMAL SAMPLE ASPIRATION ALARM OCCURRED ON THE DAY OF THE EVENT. ON ANALYSIS OF IMAGES FROM THE SAMPLE FOAM DETECTION CAMERA, A RED BLOOD CELL STRAND WAS VISIBLE WHEN THE TUBE WAS FIRST MEASURED. A FILM WAS ALSO OBSERVED ON THE SURFACE OF THE SAMPLE. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE ISSUE IS CONSISTENT WITH INCORRECT PRE-ANALYTIC SAMPLE HANDLING.