EPOC READER, HOST
Received Oct 26, 2020 · Event occurred Oct 5, 2020
Report 3002637618-2020-00057 · MDR key 10735760
Device
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER WAS UNABLE TO PROVIDE INSTRUMENT LOG FILES FOR THIS ISSUE. EPOC CALCULATED HGB IS DERIVED FROM THE HEMATOCRIT (HCT) READING ON THE EPOC DEVICE. THEREFORE, THE INVESTIGATION FOCUSED ON HCT PERFORMANCE OF THE CARD LOT 01-20176-40. A REVIEW OF THE IN-HOUSE PERFORMANCE FOR THE CARD LOT 01-20176-40 DID NOT IDENTIFY ANY PRODUCT DEFICIENCIES FOR HCT. THE FAILURE RATE OF LOT 01-20176-40 IS NOT SHOWING AN INCREASED TREND IN THE FIELD, THEREFORE, THERE IS NO FURTHER EVIDENCE THAT THE SYSTEM OR REAGENT CARDS ARE NOT PERFORMING AS INTENDED.THE CAUSE OF THIS EVENT IS UNKNOWN.
Additional Manufacturer Narrative
THE CUSTOMER STATED THAT REPEAT TESTING WAS PERFORMED TO CONFIRM CORRECT RESULTS WHICH MET THE CLINICAL PICTURE AND A CORRECTED REPORT WAS ISSUED. THE CUSTOMER WAS UNABLE TO CONFIRM IF PROPER TECHNIQUE, OR SAMPLE HANDLING WAS USED. THE INSTRUMENT LOG FILES ARE NO LONGER AVAILABLE FOR INVESTIGATION. INVESTIGATION INTO THE PERFORMANCE OF THE TEST CARD LOT IS UNDERWAY. THE CAUSE OF THIS EVENT IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED DISCREPANT THB RESULTS COMPARED TO REPEAT TESTING ON A NON-SIEMENS INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.