ALBUMIN BCP

Additional Manufacturer Narrative

THE INVESTIGATION CONFIRMED THAT COMPETITOR 1 USES THE BROMOCRESOL GREEN (BCG) LABORATORY METHOD. THE INVESTIGATION CONFIRMED THE HIGHER ALBUMIN RESULTS OBTAINED BY THE CUSTOMER FROM THE COMPETITOR'S METHOD COMPARED TO THE ALBUMIN BCP. THE INVESTIGATION DETERMINED THAT DIFFERENCES IN THE SPECIFICITY OF THE REACTION PRINCIPLES HAD CAUSED THE EVENT. A GENERAL REAGENT ISSUE IS UNLIKELY BECAUSE THE QCS ARE ACCEPTABLE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ALBUMIN BCP RESULTS FROM SOME PATIENT SAMPLES TESTED ON THE COBAS C 503 ANALYTICAL UNIT. THE RESULTS FROM THE ANALYZER WERE COMPARED TO TWO COMPETITOR ANALYZERS (COMPETITOR 1 AND COMPETITOR 2). COMPETITOR 1'S LABORATORY METHOD IS UNKNOWN; COMPETITOR 2 USES THE BROMOCRESOL GREEN (BCG) LABORATORY METHOD. THE REPORTER PROVIDED THE FOLLOWING EXAMPLES OF QUESTIONABLE RESULTS: PATIENT SAMPLE 1 THE INITIAL RESULT FROM THE ANALYZER IS 29 G/L. THE REPEAT RESULT FROM COMPETITOR 1 IS 36 G/L. THE REPEAT RESULT FROM COMPETITOR 2 IS 36 G/L. PATIENT SAMPLE 2 THE INITIAL RESULT FROM THE ANALYZER IS 28 G/L. THE REPEAT RESULT FROM COMPETITOR 1 IS 34 G/L. THE REPEAT RESULT FROM COMPETITOR 2 IS 34 G/L. PATIENT SAMPLE 3 THE INITIAL RESULT FROM THE ANALYZER IS 41 G/L. THE REPEAT RESULT FROM COMPETITOR 1 IS 47 G/L. THE REPEAT RESULT FROM COMPETITOR 2 IS 48 G/L. THE REPORTER STATED THAT THE DIFFERENT RESULTS FROM THE DIFFERENT ANALYZERS MAKE PATIENT CARE AND TREATMENT DIFFICULT FOR DOCTORS.

Additional Manufacturer Narrative

THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE INVESTIGATION INCLUDED A REVIEW OF THE QC DATA; THE RESULTS WERE WITHIN THE +/- 2 STANDARD DEVIATION RANGE. THE INVESTIGATION IS ONGOING.