MalfunctionDEX
IMMAGE CAL 1
Received Nov 15, 2011 · Event occurred Jun 18, 2010
Report 2050012-2011-07348 · MDR key 2393374
Device
Product problems
- Break
- Leak/Splash
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT AN IMMAGE CALIBRATOR REAGENT CONTAINER WAS RECEIVED AT THE WAREHOUSE DAMAGED AND LEAKING. 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 (B)(4), 2008 AND (B)(4), 2010 FOR ADDITIONAL REPORTABLE EVENTS.