MalfunctionGHM
SICKLEDEX TUBE TEST OF HEMOGLOBIN S
Received Jul 23, 2003 · Event occurred Jul 15, 2003
Report 2250051-2003-00919 · MDR key 473989
Device
Generic name
Na
Manufacturer
Ortho-clinical Diagnostics, Inc.Model number
NICatalog number
773200
Lot number
1195
Product problems
- Incorrect Or Inadequate Test Results
Patient
NO INFO
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT A PT WITH A HEMOGLOBIN S OF 22%, AS DETERMINED BY HEMOGLOBIN ELECTROPHORESIS, TESTED NEGATIVE WITH THIS PRODUCT. NO REPORTED DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.