ELECSYS PROBNP II

Additional Manufacturer Narrative

THE COBAS E411 DISK SYSTEM SERIAL NUMBER WAS (B)(6). THE CALIBRATION AND QC WERE ACCEPTABLE. THE CUSTOMER RECEIVED "REAGENT HOVERING" ALARMS. THE CUSTOMER REPLACED THE REAGENT PACK AND THE ISSUE WAS RESOLVED. A GENERAL REAGENT ISSUE CAN BE EXCLUDED, AS A DIFFERENT REAGENT KIT FROM THE SAME LOT PERFORMED ACCORDING TO EXPECTATIONS AT THE CUSTOMER SITE. THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED, HOWEVER, THE EVENT IS CONSISTENT WITH A STORAGE OR TRANSPORTATION ISSUE.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT LOW RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS PROBNP G2 (PROBNP II) ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER (DISK SYSTEM). INITIAL RESULT: 10 PG/ML (ACCOMPANIED BY A DATA FLAG). THE INITIAL RESULT DID NOT MATCH THE PATIENT'S HISTORY RESULTS. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY AND THE SAMPLE WAS REPEATED. 1ST REPEAT RESULT: 35000 PG/ML (TESTED ON A COBAS PURE ANALYZER AND ACCOMPANIED BY A DATA FLAG). 2ND REPEAT RESULT: 10 PG/ML (TESTED ON THE E411 AND ACCOMPANIED BY A DATA FLAG). 3RD REPEAT RESULT: 35000 PG/ML (TESTED ON THE E411 USING A NEW REAGENT PACK OF THE SAME LOT AND ACCOMPANIED BY A DATA FLAG). THE 3RD REPEAT RESULT WAS DEEMED TO BE CORRECT.