ELECSYS FSH

Additional Manufacturer Narrative

SECTION D4 WAS UPDATED. CORRECTION: THE COBAS 6000 CORE UNIT E601 MODULE SERIAL NUMBER WAS (B)(6) INSTEAD OF (B)(6). THE CALIBRATION FOR LOT NUMBER 850527 WAS WITHIN EXPECTATION. THE CHART SHOWED THAT THE CALIBRATION BEFORE THAT HAD SOME ISSUES. A GENERAL REAGENT OR ANALYZER PROBLEM CAN BE EXCLUDED BECAUSE THE QC PRIOR TO THE EVENT WAS WITHIN RANGES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS FOLLICLE STIMULATING HORMONE (FSH) ASSAY ON A COBAS 6000 CORE UNIT. INITIAL RESULT: 7.52 MIU/ML. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S PREVIOUS RESULTS. REPEAT RESULT: 19.10 MIU/ML. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

Additional Manufacturer Narrative

THE FSH REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE COBAS 6000 CORE UNIT SERIAL NUMBER WAS (B)(6). THE QC WAS WITHIN THE ASSIGNED RANGES ON THE DAY OF THE EVENT. THE INVESTIGATION IS ONGOING.