OtherJIO
MULTISTIX 10SG STRIPS
Received Nov 22, 2013 · Event occurred Sep 15, 2013
Report 1217157-2013-00222 · MDR key 3535810
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED 1+ TO 2+ WHITE BLOOD CELL RESULTS ON THE MULTISTIX STRIP VISUALLY WHEREAS MICROSCOPIC RESULT WAS LARGE FOR THE WHITE BLOOD CELLS. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.
Additional Manufacturer Narrative
ONE BOTTLE OF THE MULTISTIX 10 SG FROM THE CUSTOMER WAS RETURNED FOR INVESTIGATION. NO SAMPLE FROM THE PT WAS PROVIDED. SIEMENS TECHNICAL OPERATIONS COMPLETED THEIR TESTING BUT WERE UNABLE TO CONFIRM THE CUSTOMERS OBSERVATIONS. THE CAUSE FOR THE DISCORDANT WHITE BLOOD CELL RESULT IS UNKNOWN.