COULTER ACT 5 DIFF WBC LYSE
Received Sep 17, 2014 · Event occurred Aug 21, 2014
Report 1061932-2014-02354 · MDR key 4097384
Device
Generic name
Products, Red-cell Lysing Products
Manufacturer
Beckman CoulterModel number
NACatalog number
8547170
Lot number
19002B
Product problems
- High Test Results
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED HIGH CV (COEFFICIENT OF VARIATION) WAS OBTAINED FOR THE WHITE BLOOD CELL (WBC) PARAMETER WHEN USING THE COULTER ACT 5 DIFF CAP PIERCE (CP). THE CUSTOMER PERFORMED TROUBLESHOOTING BY COMPLETING EXTENDED CLEANING. THE PROBLEM WAS NOT RESOLVED AND A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. THE FSE IDENTIFIED CRYSTALS / PRECIPITATE / PARTICLES IN THE ACT 5DIFF WBC LYSE REAGENT. THERE WAS NO REPORT OF ERRONEOUS TEST RESULTS REPORTED OUT OF THE LABORATORY FOR THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.
Additional Manufacturer Narrative
ON (B)(4) 2014, THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND IDENTIFIED THE ACT5DIFF WBC LYSE REAGENT SHOWED CRYSTAL PARTICLES. THE FSE FLUSHED THE SYSTEM AND INSTALLED A FRESH BOTTLE OF WBC LYSE REAGENT AND VERIFIED IT WAS CLEAR OF ANY PRECIPITATE. THE FSE PERFORMED VERIFICATION AND VALIDATION, ALL WITHIN SPECIFICATION. (B)(4).