ALB2 ALBUMIN GEN.2

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE ANALYZER WAS (B)(6). CALIBRATION AND QC DATA WERE ACCEPTABLE. A REVIEW OF THE ALARM TRACE SHOWED FEW ABNORMAL ASPIRATION ALARMS PRESENT ON THE DAY OF THE EVENT. INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ALBUMIN GEN.2 ASSAY RESULTS FOR TWO PATIENT SAMPLES ON A COBAS 8000 C702 MODULE. BOTH SAMPLES WERE REPEATED AS THE RESULTS DID NOT MATCH THE PATIENT'S HISTORY. SAMPLE 1: THE INITIAL RESULT WAS < 2 G/L. THE REPEATED RESULT WAS 51.5 G/L. SAMPLE 2: THE INITIAL RESULT WAS < 2 G/L. THE REPEATED RESULT WAS 44 G/L. NONE OF THE RESULTS WERE REPORTED OUT.

Additional Manufacturer Narrative

A GENERAL REAGENT ISSUE WAS EXCLUDED AS CALIBRATION AND QC DATA WERE ACCEPTABLE. THE ANALYZER ALARM TRACE CONTAINED SAMPLE HANDLING-RELATED ALARMS WHICH INDICATE A PREANALYTICAL ISSUE IN THE LAB. THE INVESTIGATION DETERMINED THE ISSUE WAS CONSISTENT WITH PRE-ANALYTICAL HANDLING ISSUES AT THE CUSTOMER SITE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.