ACT 5DIFF RINSE
Received Jun 18, 2013 · Event occurred May 21, 2013
Report 1061932-2013-01158 · MDR key 3176028
Device
Generic name
Detergent
Manufacturer
Beckman CoulterModel number
NACatalog number
8547167
Lot number
13002C00357
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) ASSISTED THE CUSTOMER OVER THE PHONE ON (B)(4) 2013. THE CUSTOMER INDICATED THAT THERE WAS VISIBLE WHITE RESIDUE OBSERVED IN THE REAGENT BOTTLE, LOT NUMBER 13002C00357. THE FSE HAD THE CUSTOMER REPLACE RINSE REAGENT TO ONE OF A NEW LOT AND PRIME THE NEW REAGENT. ADDITIONALLY, THE SYSTEM WAS CLEANED WITH 50/50 BLEACH/WATER SOLUTION AND BACK FLUSH WAS PERFORMED. THE CUSTOMER ALSO PERFORMED AN EXTENDED CLEANING PROCEDURE. THE FSE FOLLOWED UP THE FOLLOWING DAY, (B)(4) 2013, TO VERIFY THE OPERATION OF THE INSTRUMENT. PER CONVERSATION WITH THE CUSTOMER ON (B)(4) 2013, THERE HAVE BEEN NO FURTHER ISSUES SINCE CHANGING TO A NEW LOT. FAILURE MODE WAS ATTRIBUTED TO CONTAMINATED ACT 5 DIFF RINSE REAGENT.
Description of Event or Problem
THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) AN ONGOING PROBLEM WITH WHITE BLOOD COUNT (WBC) VOTE-OUTS ON THE COULTER AC T 5DIFF CP ANALYZER. PER CONVERSATION WITH THE CUSTOMER, THE ISSUE WAS OCCURRING ON CONTROLS AND PATIENT SAMPLES. THE INSTRUMENT PRINTOUTS FOR THIS OCCURRENCE WERE NOT PROVIDED FOR REVIEW. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO DEATH, INJURY OR EFFECT TO PATIENT TREATMENT.