ELECSYS PROBNP II

Additional Manufacturer Narrative

CALIBRATION WAS LAST PERFORMED ON (B)(6) 2022. PER PRODUCT LABELING, "RENEWED CALIBRATION IS RECOMMENDED AS FOLLOWS: AFTER 12 WEEKS WHEN USING THE SAME REAGENT LOT; AFTER 7 DAYS WHEN USING THE SAME REAGENT KIT ON THE ANALYZER." QC DATA RECOVERY SHOWED THE LEVEL ONE CONTROL WAS OUT OF RANGE BEFORE BEING REPEATED SUCCESSFULLY. IT WAS FOUND THAT THE CUSTOMER IS USING SAMPLE TUBES MEASURING 15 X 92 MM. PER PRODUCT LABELING, THE PRIMARY SAMPLE TUBE SIZE REQUIREMENTS FOR THE ANALYZER ARE 13 X 75 MM, 16 X 75 MM, 13 X 100 MM, OR 16 X 100 MM. IT WAS ALSO FOUND THAT THE CUSTOMER TOOK THE REAGENT OUT OF THE REFRIGERATOR 30 MINUTES PRIOR TO MEASUREMENT, WHICH MAY NOT BE ENOUGH TIME TO BRING THE REAGENT TEMPERATURE TO THE CORRECT WORKING TEMPERATURE AS INDICATED IN PRODUCT LABELING. BASED ON THE AVAILABLE DATA, A GENERAL REAGENT PROBLEM COULD BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS PROBNP II IMMUNOASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE INITIAL PROBNP RESULT WAS 10 PG/ML WITH FLAG. THE REPEAT RESULT WAS 10470 PG/ML. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS DEEMED CORRECT. THE ANALYZER SERIAL NUMBER IS (B)(4).

Additional Manufacturer Narrative

THE CUSTOMER REPLACED THE PINCH TUBES. THE INVESTIGATION IS ONGOING.