ELECSYS PROBNP II

Additional Manufacturer Narrative

THE LAST CALIBRATION PERFORMED ON (B)(6) 2022 WAS WITHIN EXPECTATIONS. UPON REVIEW OF QUALITY CONTROL DATA, CONTROLS WERE LAST TESTED ON (B)(6) 2022 AND NOT ON THE DATE OF THE EVENT. PER PRODUCT LABELING: "CONTROLS FOR THE VARIOUS CONCENTRATION RANGES SHOULD BE RUN INDIVIDUALLY AT LEAST ONCE EVERY 24 HOURS WHEN THE TEST IS IN USE, ONCE PER REAGENT KIT, AND FOLLOWING EACH CALIBRATION." BASED ON THE INFORMATION, A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS PROBNP II IMMUNOASSAY VER. 2.1 ON A COBAS 6000 E 601 MODULE (SERIAL NUMBER (B)(4)). NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. NO UNITS OF MEASURE WERE PROVIDED. THE SAMPLE INITIALLY RESULTED IN A PROBNP VALUE OF > 35000. THE SAMPLE WAS REPEATED USING THE BIOMEREUX VIDAS METHOD, RESULTING IN A VALUE OF 15000. THE CUSTOMER THEN REPLACED THE PROBNP REAGENT PACK ON THE E601 ANALYZER AND REPEATED THE SAMPLE ON THE E601, RESULTING IN A VALUE THAT MATCHED THE 15000 VALUE MEASURED WITH THE VIDAS METHOD.