OtherJIO
MULTISTIX 10SG STRIPS
Received Jul 19, 2013 · Event occurred Jun 5, 2013
Report 1217157-2013-00131 · MDR key 3252626
Device
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CAUSE FOR THE DISCORDANT RESULTS IS UNK.
Description of Event or Problem
CUSTOMER REPORTED NEGATIVE RESULTS FOR WHITE BLOOD CELLS (WBCS), BLOOD AND NITRITES VISUALLY BUT THE REFERENCE LAB RESULTS WERE POSITIVE. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.