ACCESS® FREE T4 REAGENT
Received Jun 10, 2011 · Event occurred May 6, 2011
Report 2122870-2011-01804 · MDR key 2120787
Device
Generic name
Free Thyroxine Test System
Manufacturer
Beckman Coulter, Inc.Catalog number
33880
Lot number
018460
Product problems
- Low Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
EVALUATION AND TROUBLESHOOTING ACTIVITIES WERE CONDUCTED VIA TELEPHONE. BCI RECOMMENDED THAT THE CUSTOMER ESTABLISH A REFERENCE RANGE FOR FREE T4 (TO UPDATE THE RANGE THAT WAS CURRENTLY IN USE SINCE IT WAS UNKNOWN HOW THE CURRENT RANGE WAS ESTABLISHED).
Description of Event or Problem
THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT LOWER THAN EXPECTED RESULTS FOR FREE THYROXINE (FREE T4) FOR PATIENT SAMPLES ASSAYED USING THE ACCESS FREE T4 REAGENT ON AN ACCESS 2 IMMUNOASSAY SYSTEM. THE PATIENT RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. IT IS CURRENTLY UNKNOWN THE NUMBER OF IMPACTED PATIENT SAMPLES. SEVERAL REQUESTS HAVE BEEN MADE TO THE CUSTOMER FOR PATIENT SAMPLE DATA. TO DATE, NO DATA HAVE BEEN RECEIVED FROM THE CUSTOMER. ALL QUALITY CONTROL RESULTS FOR FREE T4 WERE WITHIN THEIR RESPECTIVE RANGES. THE CUSTOMER WAS NOT EXPERIENCING ANY ISSUES WITH THE OTHER ASSAYS ON THE ANALYZER. FURTHER DISCUSSION WITH THE CUSTOMER REVEALED THAT THE REFERENCE RANGE IN USE AT THE TIME FOR FREE T4 WAS 0.8-1.8 NG/DL. THE CUSTOMER WAS NOT AWARE HOW THIS RANGE WAS DETERMINED FOR THEIR LABORATORY. BCI COMMUNICATED TO THE CUSTOMER THAT THE PUBLISHED RANGE IN THE BCI INSTRUCTIONS FOR USE FOR FREE T4 IS 0.61-1.12 NG/DL. BCI RECOMMENDED THAT THE CUSTOMER ESTABLISH A REFERENCE RANGE FOR FREE T4 OR TO REVIEW PUBLISHED REFERENCE RANGES TO COMPARE AGAINST THEIR CURRENT RANGE.