MalfunctionKQO

QUANTI MATRIX DROPPER

Received Jul 14, 2011 · Event occurred Jul 1, 2011

Report MW5021351 · MDR key 2166686

Device

Generic name

Urinalysis Dipstick

Manufacturer

Crunin Diagnostics Ltd.

Product problems

Inadequate Instructions for Healthcare Professional
Inadequate Instructions for Non-Healthcare Professional

Patient

Not reported

No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

PACKAGE INSERTS OF EACH PRODUCT DO NOT AGREE ON PROPER PROCEDURE. THESE PRODUCTS ARE INTENDED TO BE USED TOGETHER, HOWEVER, MFRS DO NOT AGREE ON INSTRUCTIONS FOR USE. THIS CREATES CONFUSION ON CORRECT TESTING PROCEDURES INSIDE /OUTSIDE LAB WHEN TRYING TO ESTABLISH BEST PRACTICE. THERE HAVE BEEN NO SAFETY OR INTEGRITY ISSUES. THIS REMAINS A CONTROLLED TEST, BUT IS NOT USER FRIENDLY DUE TO INCONSISTENCIES IN MFR INSTRUCTIONS FOR USE. ONE PRODUCT STATES TO DIP IN SPECIMEN FOR 1-2 SECONDS, THE OTHER DIRECTS THE USER TO LET THE DROP TOUCH THE STRIP.