MalfunctionCIT
ASPARTATE AMINOTRANSFERASE PYRIDOXAL-5'-PHOSPHASE REAGENT
Received Nov 15, 2011 · Event occurred May 21, 2010
Report 2050012-2011-07388 · MDR key 2393378
Device
Product problems
- Leak/Splash
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
INTERNATIONAL CUSTOMER REPORTED THAT THE SYNCHRON ASPARTATE AMINOTRANSFERASE PYRIDOXAL-5'-PHOSPHASE (AST) REAGENT CARTRIDGE LEAKED. NO INJURIES WERE REPORTED.
Additional Manufacturer Narrative
NO PRODUCT WAS RETURNED FOR EVALUATION, ACCORDINGLY, NO CONCLUSION CAN BE DRAWN. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.