MalfunctionGGK
DXH CELL LYSE
Received Feb 26, 2012 · Event occurred Feb 1, 2012
Report 1061932-2012-00606 · MDR key 2468689
Device
Generic name
Products, Red-cell Lysing Products
Manufacturer
Beckman Coulter, Inc.Catalog number
8547170
Lot number
16202B
Product problems
- Leak/Splash
- Device Slipped
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THEY RECEIVED A BOTTLE OF AC T 5 DIFF WBC LYSE THAT WAS LEAKING DUE TO A LOOSE CAP. THERE WAS NO REPORT OF PATIENT RESULTS AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.
Additional Manufacturer Narrative
(B)(4).