MULTISTIX 10SG STRIPS
Received Jan 13, 2014 · Event occurred Nov 25, 2013
Report 1217157-2013-00260 · MDR key 3601616
Device
Product problems
- False Positive Result
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED 27 FALSE POSITIVE UROBILINOGEN RESULTS USING DETERIORATED MULTISTIX 10SG TEST STRIPS. CUSTOMER INDICATED THAT THEY HAVE BEEN RUNNING PATIENT SAMPLES ON THESE TEST STRIPS SINCE (B)(6) 2013. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.
Additional Manufacturer Narrative
CUSTOMER INDICATED THAT THEY RUN PATIENT SAMPLES EVEN WHEN THE QUALITY CONTROL (QC) FAILED. CUSTOMER SHOULD NOT HAVE RUN THE PATIENT SAMPLES WHEN QC WAS FAILED. CUSTOMER HAS BEEN PROVIDED WITH NEW BOTTLE OF MULTISTIX 10SG STRIPS. CUSTOMER INDICATED THAT THE ISSUE IS RESOLVED WITH A NEW LOT OF MULTISTIX 10SG STRIPS. THE EVENT HAS OCCURRED DUE TO AN OPERATOR ERROR.