MalfunctionGHM
SICKLEDEX TUBE TEST FOR HEMOGLOBIN S
Received Apr 3, 2006 · Event occurred Mar 2, 2006
Report 2250051-2006-50140 · MDR key 695791
Device
Generic name
*
Manufacturer
Ortho-clinical Diagnostics, Inc.Model number
NACatalog number
773500
Lot number
5250
Product problems
- False Negative Result
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED A FALSE NEGATIVE RESULT WAS OBTAINED WHEN THE SAMPLE WAS TESTED WITH SICKLEDEX LOT 5250. CUSTOMER RESULTS WERE SATISFACTORY. CUSTOMER OBTAINED A POSITIVE RESULT FOR THE PATIENT'S SAMPLE VIA ELECTROPHORESIS. NO DEATH OR SERIOUS INJURY IS ASSOCIATED WITH THIS EVENT.