MalfunctionDGR
ANTI-D BIOCLONE
Received Jan 9, 2008 · Event occurred Dec 4, 2007
Report 2250051-2008-00020 · MDR key 2948681
Device
Generic name
Blood Grouping Reagent
Manufacturer
Ortho-clinical DiagnosticsModel number
NACatalog number
717380
Lot number
DB265A
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT A PT, PREVIOUSLY TYPED AS WEAK D NEGATIVE, RETURNED TO THE FACILITY ONE WEEK LATER AND A 3+ REACTION WAS OBSERVED AT IMMEDIATE SPIN. CUSTOMER STATED THAT QUALITY CONTROL TESTING HAD BEEN SATISFACTORY AT BOTH TIMES. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT. (B)(4).
Additional Manufacturer Narrative
ORTHO-CLINICAL DIAGNOSTICS (OCD) QA PERFORMED RETAINED TESTING. D+, WEAK D+, AND D- CELLS REACTED AS EXPECTED. RESULTS WERE SATISFACTORY.