MalfunctionCKA
ALT IFCC WITHOUT P-5-P
Received Aug 25, 2004 · Event occurred Aug 10, 2004
Report 1823260-2004-00766 · MDR key 612418
Device
Generic name
Clinical Chemistry Reagent
Manufacturer
Roche DiagnosticsModel number
NACatalog number
11877470216
Lot number
ALL
Product problems
- Unknown (for use when the device problem is not known)
Patient
NA
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
INCORRECT LOW AND ZERO PATIENT RESULTS MAY OCCUR WITH THIS REAGENT ON THE HITACHI MODULAR P ANALYZER. ROTATION OF THE INSTRUMENT REAGENT COMPARTMENT CAN CAUSE A BUBBLE TO FORM IN THE NECK OF THE REAGENT BOTTLE CAUSING PREMATURE LIQUID LEVEL DETECTION AND SHORT SAMPLING OF THE REAGENT. THIS APPEARS TO BE RELATED TO THE REAGENT FILL VOLUME, VISCOSITY, AND DESIGN OF THE BOTTOM NECK.
Remedial action
- Recall