ELECSYS TG II

Additional Manufacturer Narrative

THE PROVIDED QUALITY CONTROL DATA WAS WITHIN RANGE. A SAMPLE FROM THE PATIENT WAS REQUESTED FOR INVESTIGATION, BUT ONE COULD NOT BE PROVIDED. PER PRODUCT LABELING: "TG DETERMINATIONS CAN BE AFFECTED BY THE PRESENCE OF TG AUTOANTIBODIES CAUSING FALSE HIGH OR FALSE LOW TG VALUES. THEREFORE ANTI TG DETERMINATIONS ARE RECOMMENDED FOR ALL TG SAMPLES TO RULE OUT THIS INTERFERENCE." THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TG II ON A COBAS E 801 MODULE. THE RESULTS DID NOT COMPARE TO COMPETITOR TEST RESULTS. THE SAMPLE RESULTED IN A TG VALUE OF 96.2 NG/ML (REFERENCE RANGE = 3.5 - 7.7 NG/ML) WHEN TESTED ON THE E801 ANALYZER WITH REAGENT LOT NUMBER 702150. THE SAMPLE WAS REPEATED ON THE E801 ANALYZER USING REAGENT LOT NUMBER 730633, RESULTING IN A TG VALUE OF 98.2 NG/ML. THE PLASMA TUBE OF THE SAME SAMPLE WAS REPEATED ON THE E801 ANALYZER USING REAGENT LOT NUMBER 730633, RESULTING IN A TG VALUE OF 91.1 NG/ML. THE SAMPLE WAS REPEATED USING TWO DIFFERENT COMPETITOR METHODS. WITH THE FIRST METHOD, THE TG RESULT WAS < 0.14 NG/ML. WITH THE SECOND METHOD, THE TG RESULT WAS 0.13 NG/ML. BOTH COMPETITOR VALUES ARE WITHIN THEIR RESPECTIVE NORMAL REFERENCE RANGES. THE CUSTOMER DEEMED THE COMPETITOR'S RESULTS TO BE CORRECT.

Additional Manufacturer Narrative

THE E801 ANALYZER SERIAL NUMBER IS (B)(6). THE FIRST COMPETITOR METHOD IS THE ABBOTT ARCHITECT. THE SECOND COMPETITOR METHOD IS AN UNKNOWN RADIOIMMUNOASSAY (RIA). THE INVESTIGATION IS ONGOING.