MalfunctionCGL
EPOC READER
Received Jan 19, 2022 · Event occurred Jun 2, 2021
Report 3002637618-2022-00004 · MDR key 13289016
Device
Product problems
- Low Test Results
- Low Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SIEMENS HAS REQUESTED FURTHER INFORMATION FROM THE CUSTOMER, HOWEVER NO RESPONSE HAS BEEN RECEIVED. THEREFORE NO FURTHER INVESTIGATION CAN BE PERFORMED. SIEMENS REVIEWED THE IN-HOUSE PERFORMANCE FOR THE CARD LOT IN QUESTION AND DID NOT IDENTIFY ANY PRODUCT DEFICIENCIES. THE CAUSE OF THIS EVENT IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED DISCREPANT HEMOGLOBIN AND HEMATOCRIT RESULTS ON THEIR EPOC INSTRUMENT COMPARED TO A NON-SIEMENS HEMATOLOGY LAB INSTRUMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.