AST

Additional Manufacturer Narrative

GENERAL INSTRUMENT ISSUES WERE EXCLUDED AS ONLY THIS SINGLE INCIDENT WAS REPORTED. THERE WAS NO ALLEGATION OF ISSUES WITH CALIBRATION OR QC. AN INTERFERENCE WAS FOUND TO BE UNLIKELY AS PREVIOUS VALUES FOR THE PATIENT WERE ACCEPTABLE AND THE PATIENT WAS TAKING THE SAME MEDICATION WHEN PREVIOUS VALUES WERE GENERATED. 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. THERE IS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE.

Additional Manufacturer Narrative

THE SPECIFIC ANALYZER AND SERIAL NUMBER USED WERE NOT PROVIDED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE AST RESULTS FROM A COBAS 8000 ANALYZER. THE CUSTOMER ALLEGED THE RESULTS MIGHT NOT BE CORRECT DUE TO A POTENTIAL INTERFERENCE. THE PATIENT HAD SIMILAR RESULTS ONE MONTH AGO (NO SPECIFIC DATA PROVIDED) AND THE CUSTOMER BELIEVES THAT SOME SUBSTANCE SUCH AS A DRUG METABOLITE MAY BE AFFECTING THE RESULTS. THE INITIAL RESULT WAS 105 U/L WITH AN INVALIDATING DATA FLAG. THE REPEAT RESULT WITH A 1:5 DILUTION WAS 101.69 U/L WITH A DATA FLAG.