ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. 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 07P70-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P70, WITH 510K NUMBER K173122.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: 9.01-19.05 PMOL/L): SAMPLE 2 INITIAL 22.26, REPEATED 15.69 / 16.42 / 16.73 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: 9.01-19.05 PMOL/L): SAMPLE 2 INITIAL 22.26, REPEATED 15.69 / 16.42 / 16.73 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I FREE T4 REAGENT LOT 82597UD01 TO ADDRESS THE CUSTOMER¿S OBSERVATION OF FALSELY DEPRESSED RESULTS. REVIEW OF TRACKING AND TRENDING DATA FOR LOT 82597UD01 DID IDENTIFY AN INCREASE IN COMPLAINTS, HOWEVER, THE SEARCH BY LIST NUMBER DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE CURRENT COMPLAINT ISSUE. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. FIELD DATA ANALYSIS FOR THE MEDIAN PATIENT RESULT FOR THE REAGENT LOT 82597UD FALLS WITHIN THE ESTABLISHED BASELINE, INDICATING THE REAGENT LOT IS PERFORMING ACCEPTABLY ON MARKET. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I FREE T4 REAGENT LOT 82597UD01.