OtherCDM
ALBUSTIX
Received Aug 17, 2012 · Event occurred Jul 16, 2012
Report 1217157-2012-00034 · MDR key 2710135
Device
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
CUSTOMER REPORTED DISCORDANT ALBUSTIX RESULT ON URINE STRIP.
Additional Manufacturer Narrative
INITIAL SAMPLES TESTED WERE A RESULT OF PT URINATING DIRECTLY ON URINE TEST STRIP. LABCORP RESULT WAS OBTAINED ON A SAMPLE FROM THE PT SAMPLE IN A DIXIE CUP. PT WAS TREATED AS A RESULT OF THE ELEVATED RESULT. CUSTOMER WAS ADVISED TO SEND THE URINALYSIS STRIPS BACK TO THE MANUFACTURER FOR TESTING. RETURNED PRODUCT TESTED AND COMPLAINT WAS NOT CONFIRMED. MANUFACTURER BELIEVES USER ERROR RELATED TO COMPLAINT.