ALTL

Additional Manufacturer Narrative

FOR THE COMPLAINED SAMPLE, THE AST MEASUREMENT OF 715 U/L AND ALT MEASUREMENT OF 1027 U/L WERE REPEATS THAT WERE PERFORMED AUTOMATICALLY BY THE ANALYZER. THE SAMPLE WAS REPEATED DUE TO HIGH AST, ALT, AND GGT VALUES. THE CUSTOMER DEEMED THE VALUES MEASURED FROM THE SECOND SAMPLE TO BE CORRECT (AST = 717 U/L, ALT = 1041 U/L).

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE INTEGRA 400 PLUS ANALYZER WAS REQUESTED, BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ASTL AND ALTL ON AN INTEGRA 400 PLUS SYSTEM. THE CUSTOMER NOTED THAT THE PATIENT SAMPLE WAS ICTERIC. THIS MEDWATCH WILL APPLY TO THE ALT ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT-0066446 FOR INFORMATION RELATED TO THE AST ASSAY. THE SAMPLE INITIALLY RESULTED IN AN AST VALUE OF 77 U/L WITH A DATA FLAG. THE SAMPLE WAS REPEATED TWICE, RESULTING IN AST VALUES OF 279 U/L WITH A DATA FLAG AND 715 U/L WITH A DATA FLAG. THE SAMPLE WAS PLACED IN A CUP AND REPEATED TWICE, RESULTING IN AST VALUES OF 731 U/L WITH A DATA FLAG AND 732 U/L WITH A DATA FLAG. THE SAMPLE INITIALLY RESULTED IN AN ALT VALUE OF 36 U/L WITH A DATA FLAG AND IT REPEATED AS 1027 U/L WITH A DATA FLAG. THE SAMPLE WAS PLACED IN A CUP AND REPEATED TWICE, RESULTING IN ALT VALUES OF 1044 U/L WITH A DATA FLAG AND 1063 U/L WITH A DATA FLAG.

Additional Manufacturer Narrative

UPON REVIEW OF THE ANALYZER'S DATABASE, THE LAST ENTRY WAS FROM (B)(6) 2023. IT IS RECOMMENDED TO DELETE OLD ENTRIES TO KEEP SOFTWARE PERFORMANCE UP. IT WAS DETERMINED THAT MAINTENANCE WAS DUE FOR LAMP REPLACEMENT, VENTILATION FILTER REPLACEMENT, AND PROBE/SPLASH GUARD CLEANING. OTHER REAGENTS WERE FOUND TO HAVE EXPIRED REAGENT PACKS. A REVIEW OF THE CALIBRATION TRACE DETERMINED THE CUSTOMER IS USING AN EXPIRED CALIBRATOR. A REVIEW OF CONTROL DATA SHOWED THAT THERE IS AN EXPIRED CONTROL LOT LOGGED ON THE INSTRUMENT. ONLY ONE LEVEL OF CONTROL WAS USED AND WAS NOT PERFORMED DAILY, ONLY ONCE PER WEEK. A GENERAL REAGENT ISSUE COULD BE RULED OUT AS THE MOST RECENT CONTROL RECOVERY WAS WITHIN RANGE. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.