MalfunctionCKA
ALT (ALANINE AMINOTRANSFERASE) IFCC
Received Feb 3, 2012 · Event occurred Jan 18, 2012
Report 2050012-2012-00362 · MDR key 2438831
Device
Generic name
Nadh Oxidation/nad Reduction, Alt/sgpt
Manufacturer
Beckman Coulter, Inc.Catalog number
467840
Lot number
T106012
Product problems
- Leak/Splash
- Defective Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ON (B)(4) 2012, CUSTOMER REPORTED THAT 2 CARTRIDGES OF ALANINE AMINOTRANSFERASE (ALT) REAGENT WERE LEAKING UPON ARRIVAL AND APPEARED TO HAVE A DEFECT ALONG THE BOTTOM SEAM OF THE CARTRIDGE. NO EXPOSURE OR INJURIES WERE REPORTED AND NO ERRONEOUS PATIENT RESULTS WERE GENERATED. IT WAS DECIDED THAT AN MDR SHOULD BE FILED BECAUSE THE REAGENT CONTAINS MATERIAL OF ANIMAL ORIGIN THAT IS POTENTIALLY INFECTIOUS, AND UPON RECUR, EXPOSURE COULD RESULT IN SERIOUS INJURY.
Additional Manufacturer Narrative
(B)(4).