ARCHITECT FREE T4

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 AND PROVIDED THE FOLLOWING DATA FOR 2 SAMPLES: REFERENCE RANGE: FREE T4: 9.01-19.04 PMOL/L. SAMPLE 1: INITIAL FREE T4 TEST RESULT: 30.15, RETEST RESULT: 13.07. SAMPLE 2, INITIAL FREE T4 TEST RESULT: >64.35, RETEST RESULT: 15.91. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

COMPLETE INFORMATION FOR SECTION A1 PATIENT IDENTIFIER: 2 PATIENTS, SAMPLE 1 AND SAMPLE 2. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED, NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. 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 07K65-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07K65, 510K K173122.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, A SEARCH FOR SIMILAR COMPLAINTS, A TICKET TRENDING REVIEW, A DEVICE HISTORY RECORD REVIEW, A LABELING REVIEW, AND IN-HOUSE TESTING. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING DATA FOR THE ARCHITECT FREE T4 ASSAY DID IDENTIFY AN INCREASE IN COMPLAINTS. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS IDENTIFIED FOR REAGENT LOT 73030UD02. HOWEVER, IN-HOUSE ACCURACY TESTING WAS COMPLETED WITH A RETAINED KIT OF THE COMPLAINT LOT. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET DURING COMPLETION OF THE PROTOCOL, DEMONSTRATING THAT THE LOT IS PERFORMING AS EXPECTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NONCONFORMANCES, OR DEVIATIONS WITH LOT NUMBER AND THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ARCHITECT FREE T4 REAGENT, LOT NUMBER 73030UD02.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 AND PROVIDED THE FOLLOWING DATA FOR 2 SAMPLES: REFERENCE RANGE: FREE T4: 9.01-19.04 PMOL/L. SAMPLE 1: INITIAL FREE T4 TEST RESULT: 30.15, RETEST RESULT: 13.07. SAMPLE 2, INITIAL FREE T4 TEST RESULT: >64.35, RETEST RESULT: 15.91. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.