MalfunctionCKA
CX GLUCOSE REAGENT
Received Feb 3, 2012 · Event occurred Jan 18, 2012
Report 2050012-2012-00361 · MDR key 2438830
Device
Generic name
Hexokinase, Glucose
Manufacturer
Beckman Coulter, Inc.Catalog number
442640
Lot number
M110253
Product problems
- Leak/Splash
- Loose or Intermittent Connection
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ON (B)(4) 2012, CUSTOMER REPORTED THAT SHE RECEIVED A GLUCOSE REAGENT CARTRIDGE THAT HAD LEAKED DUE TO A LOOSE CAP. NO EXPOSURE OR INJURIES WERE REPORTED AND NO ERRONEOUS PATIENT RESULTS WERE GENERATED. BECKMAN COULTER SENT A REPLACEMENT CARTRIDGE TO THE CUSTOMER.
Additional Manufacturer Narrative
(B)(4).