EPOC READER
Received Dec 16, 2019 · Event occurred Dec 9, 2019
Report 3002637618-2019-00133 · MDR key 9476606
Device
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER STATED THAT REPEAT TESTING WAS PERFORMED TO CONFIRM CORRECT RESULTS WHICH MET THE CLINICAL PICTURE. THE CUSTOMER IS BEING SENT A NEW EPOC READER. SIEMENS HAS REQUESTED MORE INFORMATION TO PROPERLY ASSESS THIS COMPLAINT BUT TO DATE, NONE HAS BEEN RECEIVED. THE CAUSE OF THIS EVENT IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED DISCREPANT PO2 RESULTS BETWEEN THE INITIAL AND REPEAT RESULTS ON THE EPOC READER. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.
Additional Manufacturer Narrative
SIEMENS HAS REACHED OUT TO THE CUSTOMER MULTIPLE TIMES REQUESTING MORE INFORMATION TO PROPERLY ASSESS THIS COMPLAINT. NO FURTHER INFORMATION HAS BEEN RECEIVED FROM THE CUSTOMER INCLUDING THE LOT NUMBER OF THE REAGENT IN USE. WITHOUT MORE INFORMATION OR THE LOT OF REAGENT IN USE AT THE TIME OF THE DISCREPANCY, FURTHER INVESTIGATION IS NOT POSSIBLE. THE CUSTOMER WAS SENT A NEW EPOC READER. ROOT CAUSE OF THIS EVENT IS UNKNOWN.
Remedial action
- Replace