ELECSYS T4

Additional Manufacturer Narrative

THE REAGENT LOT NUMBER WAS 71166800. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE T4 RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. AFTER A FAILED CALIBRATION, THE CUSTOMER REPEATED THREE PATIENT SAMPLES FOR A PATIENT CORRELATION. SAMPLE 1 INITIAL RESULT WAS 9.29 UG/DL AND THE REPEAT RESULT WAS 13.2 UG/DL. SAMPLE 2 INITIAL RESULT WAS 5.86 UG/DL AND THE REPEAT RESULT WAS 10.9 UG/DL. SAMPLE 3 INITIAL RESULT WAS 7.3 UG/DL AND THE REPEAT RESULT WAS 11.6 UG/DL. THE INITIAL RESULTS WERE BELIEVED CORRECT.

Additional Manufacturer Narrative

MEDWATCH FIELDS D1-D4, G1, AND G4 WERE UPDATED. THE FIELD SERVICE ENGINEER CHECKED THE ANALYZER AND WAS NOT ABLE TO DETERMINE A ROOT CAUSE. HE RAN INSTRUMENT CHECKS WHICH PASSED AND LOADED A NEW REAGENT PACK. THE CUSTOMER PERFORMED CALIBRATION, QC, AND PRECISION TESTING WHICH PASSED. THE CUSTOMER REPEATED THE AFFECTED PATIENT SAMPLES AND THE RESULTS WERE CONSISTENT WITH THE CORRECT VALUES. THE INVESTIGATION WAS NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE. THE ISSUE WAS CONSISTENT WITH A HANDLING OR OTHER ISSUE WITH THE SUSPECTED REAGENT PACK.