EPOC READER
Received Dec 5, 2019 · Event occurred Nov 7, 2019
Report 3002637618-2019-00127 · MDR key 9419056
Device
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
86 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE HCT AND HGB PERFORMANCE FOR CARD LOT 00-19193-10 WILL BE INVESTIGATED. THE CUSTOMER STATED THEY ARE OPERATIONAL. THE CAUSE OF THIS EVENT IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED DISCREPANT HEMATOCRIT AND HEMOGLOBIN RESULTS ON THE EPOC READER WHEN COMPARED TO A REPEAT ON THE SAME INSTRUMENT AND A NON-SIEMENS LAB ANALYZER. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.
Additional Manufacturer Narrative
THE RAW WAVEFORM DATA (PROVIDED BY CUSTOMER) WAS ANALYZED. BASED ON THE LIMITED INFORMATION AVAILABLE, IT IS POSSIBLE A BLOOD CLOT OR SAMPLE INJECTION ISSUE OCCURRED ON THE TEST IN QUESTION, INDICATING MORE OF A SAMPLE HANDLING/USER INJECTION RELATED ISSUE THAN A PRODUCT DEFICIENCY. THE CAUSE OF THE DISCREPANCY COULD NOT BE DETERMINED. A REVIEW OF THE IN-HOUSE PERFORMANCE OF THE CARD LOT IN USE, LOT 00-19193-10, DID NOT IDENTIFY ANY PRODUCT DEFICIENCIES. IN ADDITION, A SEARCH OF THE COMPLAINT HANDLING SYSTEM (GSMS) FOR THE CARD LOT DID NOT RETURN ANY OTHER RELATED COMPLAINTS. THEREFORE, WE CONCLUDE THAT THERE IS NO INDICATION OF A FAILURE OF THE SYSTEM TO PERFORM AS INTENDED. THE CUSTOMER IS OPERATIONAL.