MalfunctionMVE

TRIAGE CARDIAC PANEL

Received Nov 21, 2001 · Event occurred Nov 11, 2001

Report MW1023458 · MDR key 362119

Device

Generic name

Fluorescence Immunoassay

Manufacturer

Biosite Diagnostics

Model number

Catalog number

9700

Lot number

W24165B

Product problems

False Negative Result

Patient

Narrative

Description of Event or Problem

SIX TOTAL PT CARTRIDGES OF BIOSITE TRIAGE CARDIAC PANEL TESTED 0.0 FOR MYOGLOBIN. THESE CAME FROM THE SAME BOX. NINE OTHER BOXES OF THE SAME LOT NUMBER RECEIVED ON THE SAME SHIPMENT HAD BEEN TESTED. OF THE 325 TESTS NO OTHER FALSE ZEROS WERE OBTAINED.