ARCHITECT HE4 REAGENT KIT

Additional Manufacturer Narrative

A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ARCHITECT HE4 REAGENT LOT 73537FP01 TO ADDRESS THE CUSTOMER¿S OBSERVATION OF FALSELY DEPRESSED RESULTS. REVIEW OF TRACKING AND TRENDING BY LIST NUMBER AND BY COMPLAINT LOT DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH LOT 73537FP01 AND THE COMPLAINT ISSUE. THE CUSTOMER USED LOT 73537FP01 (EXPIRATION DATE; 01/21/2026) ON (B)(6) 2026 WHICH IS PAST THE EXPIRATION DATE OF THE PRODUCT. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT HE4 REAGENT LOT 73537FP01 WAS IDENTIFIED. BASED ON THE INFORMATION WITHIN THE COMPLAINT RECORD, THE DEVICE MET PERFORMANCE SPECIFICATIONS AND PERFORMED AS INTENDED AT THE CUSTOMER SITE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT HE4 RESULTS FOR A 54-YEAR-OLD FEMALE WITH OVARIAN CANCER. THE FOLLOWING DATA WAS PROVIDED: HE4 INITIAL RESULT WAS 69.1 PMOL/L, RETEST RESULT 68.8 PMOL/L (NORMAL REFERENCE RANGE 0-70 PMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 02P54-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2P54-27, WITH 510K NUMBER K093957. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT HE4 RESULTS FOR A 54-YEAR-OLD FEMALE WITH OVARIAN CANCER. THE FOLLOWING DATA WAS PROVIDED: HE4 INITIAL RESULT WAS 69.1 PMOL/L, RETEST RESULT 68.8 PMOL/L (NORMAL REFERENCE RANGE 0-70 PMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.