COULTER ACT 5DIFF CONTROL PLUS
Received Nov 18, 2011 · Event occurred Oct 26, 2011
Report 1061932-2011-02252 · MDR key 2341585
Device
Generic name
Mixture, Hematology Quality Control
Manufacturer
Beckman Coulter, Inc.Catalog number
7547198
Lot number
1111
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ON (B)(6) 2011 CUSTOMER REPORTED THAT SOME OF THEIR CONTROL VIALS, MAINLY THEIR HIGH LEVEL VIAL OF THE ACT 5 DIFF CONTROL, WAS FOUND TO BE LEAKING AS PART OF A DELIVERY TO THE LAB. HOWEVER, BASED ON FURTHER INFORMATION FROM THE CUSTOMER THE VIALS WERE FOUND TO BE LEAKING AFTER REMOVING THE VIALS FROM THE REFRIGERATOR A FEW DAYS LATER. CUSTOMER STATED THAT THERE WAS NO VISUAL DAMAGE TO THE VIALS. REPLACEMENT VIALS WERE SENT TO THE CUSTOMER. NO INJURIES WERE REPORTED AND NO ERRONEOUS PATIENT RESULTS WERE GENERATED.
Additional Manufacturer Narrative
(B)(4).