SYNCHRON® ALT REAGENT, 2 X 200 TEST
Received Jul 26, 2011 · Event occurred Jun 21, 2011
Report 2050012-2011-03626 · MDR key 2178375
Device
Generic name
Nadh Oxidation/nad Reduction, Alt/sgpt
Manufacturer
Beckman Coulter, Inc.Catalog number
442620
Lot number
M102250
Product problems
- Leak/Splash
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
BEC EVALUATED THE PHOTOGRAPHS OF THE AFFECTED REAGENT CARTRIDGE AND KIT BOX. LIQUID WAS VISIBLE ON ALT REAGENT CARTRIDGE ALTHOUGH THERE WAS NO LOOSENING OF THE CAP. THE SHIPPING BOX CONTAINED ANOTHER REAGENT, SYNCHRON CHOL (CHOLESTEROL) REAGENT, WHICH HAD LOOSE CAP AND LEAKED. THIS REAGENT IS NON-HAZARDOUS. IT IS POSSIBLE THAT THE LEAK WAS FROM CHOL REAGENT AND NOT FROM ALT, BUT COULD NOT BE CONFIRMED. NOTE: LISTED BELOW IS INFORMATION REGARDING SYNCHRON CHOL REAGENT: CATALOGUE NUMBER: 467825, LOT NUMBER: M101676, DATE OF MANUFACTURING: 02/24/2011, EXPIRATION DATE: 02/29/2012, 510(K): K971505. (B)(4).
Description of Event or Problem
AN EMPLOYEE OF BECKMAN COULTER AT (B)(4) REPORT A FLUID LEAK FROM SYNCHRON ALT (ALANINE AMINOTRANSFERASE) REAGENT. THE LEAK WAS FOUND DURING RECEIVING INSPECTION, AND THE OPERATOR WAS WEARING PPE. THERE WAS NO EXPOSURE TO UNCOVERED WOUNDS OR MUCOUS MEMBRANES. NO INJURY WAS REPORTED MSDS WAS REVIEWED, AND THE FACILITY HAS EXPOSURE CONTROL PLAN. MEDICAL ATTENTION WAS NOT SOUGHT AND THERE WAS NO EFFECT TO PATIENT OR USER.