MalfunctionJPK
4C-ES CELL CONTROL
Received Dec 7, 2011 · Event occurred Oct 17, 2011
Report 1061932-2011-02583 · MDR key 2362421
Device
Generic name
Mixture, Hematology Quality Control
Manufacturer
Beckman Coulter, Inc.Model number
4C-ESCatalog number
7547187
Lot number
1685283K/ 089800
Product problems
- Break
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ON (B)(6) 2011, CUSTOMER REPORTED A LEAK OF CONTROL MATERIAL BECAUSE THE 4C CONTROL VIAL CAPS WERE RECEIVED BROKEN FOR THE ACT DIFF2 INSTRUMENT. THE EVENT HAPPENED IN OCTOBER BUT WAS RECENTLY REPORTED BECAUSE OF A SHORTAGE OF CONTROL MATERIAL. NO INJURIES WERE REPORTED AND NO ERRONEOUS PATIENT RESULTS WERE GENERATED. CUSTOMER WAS SENT A REPLACEMENT 4C ES CONTROL PACK. SERVICE WAS NOT DISPATCHED FOR THIS EVENT.
Additional Manufacturer Narrative
(B)(4).