BECKMAN COULTER ACCESS TOTAL T3
Received Sep 18, 2003 · Event occurred Aug 1, 2003
Report MW1029611 · MDR key 488463
Device
Product problems
- High Test Results
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
CHEMISTRY INSTRUMENT FOR TOTAL T3 TESTING CHANGED IN JULY 2003 AFTER EXTENSIVE VALIDATION TESTS. IN AUGUST REVIEW OF PT TESTING SHOWED HIGHER THAN NORMAL NUMBER OF ELEVATED TOTAL T3 LEVELS. RETESTING AND INVESTIGATION REVEALED THAT THE CO CHANGED ITS REAGENT WITH NO LEAD TIME NOTICE PROVIDED TO REPORTER AT THE TIME. SAMPLES FROM ORIGINAL VALIDATION WERE RETESTED BY ANOTHER HOSP WHICH USES SAME REAGENT AND MANUFACTURER AND SAME HIGHER RESULTS WERE DEMONSTRATED. REPORTER ALSO SENT TO INDEPENDENT LAB AT THEIR EXPENSE; TESTS SHOWED APPROPRIATE TOTAL T3 LEVELS. REPORTER IS NOW SENDING TOTAL T3 TO ANOTHER LAB UNTIL THE PROBLEM CAN BE CORRECTED. CO CONTACTED- THEY RETESTED VALIDATION SAMPLES AND FOUND DISCREPANCIES AS WELL.