EPOC HOST
Received Jul 16, 2020 · Event occurred Jun 16, 2020
Report 3002637618-2020-00034 · MDR key 10286296
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
INVESTIGATION RESULTS: THE CAUSE OF THE CHGB DISCREPANCY COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. A REVIEW OF THE IN-HOUSE PERFORMANCE FOR THE CARD LOT USED, LOT 01-20029-20, DID NOT IDENTIFY ANY PRODUCT DEFICIENCIES. THE FAILURE RATE OF LOT 01-20029-20 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 CUSTOMER'S INSTRUMENT IS NOT CURRENTLY IN USE AS IT WAS RETURNED IT TO THE REPAIR FACILITY. THE CUSTOMER RECEIVED A REPLACEMENT AND IS OPERATIONAL WITH A NEW INSTRUMENT AT THIS TIME. THE CAUSE OF THIS EVENT IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED DISCREPANT TOTAL HEMOGLOBIN RESULTS ON THE EPOC HOST WHEN COMPARED TO A NON-SIEMENS LAB INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Remedial action
- Replace