EPOC READER
Received Jan 20, 2022 · Event occurred Dec 29, 2021
Report 3002637618-2022-00007 · MDR key 13307530
Device
Product problems
- High Test Results
- High Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER COMPARED RESULTS THAT WERE TAKEN THREE WEEKS APART. NO COMPARATIVE TESTING WAS PERFORMED AT THE TIME THE DISREPANT RESULT WAS RECEIVED. THE CUSTOMER STATED THAT THEY EXPECTED A RESULT CLOSER TO THAT RECEIVED PREVIOUSLY DUE TO THE PATIENT'S CLINICAL PICTURE. THE CUSTOMER ALSO STATED THAT EXPIRED CAPILLARY TUBE WERE USED TO OBTAIN THE SAMPLE. SIEMENS REVIEWED IN-HOUSE PERFORMANCE DATA OF THE LOT IN QUESTION AND FOUND NO PRODUCT DEFICIENCIES. ADDITIONALLY, IT WAS NOTED THE CUSTOMER WAS USING EARLOBE CAPILLARY SAMPLES. THE PROCESS OF CAPILLARY COLLECTION MAY CHANGE PO2 LEVELS SIGNIFICANTLY AND IS SUSCEPTIBLE TO FACTORS SUCH AS AIR CONTAMINATION. ACCORDING TO CLSI C46-A BLOOD GAS AND PH ANALYSIS AND RELATED MEASUREMENTS; APPROVED GUIDELINE, ARTERIAL BLOOD SAMPLES ARE PREFERRED FOR BLOOD GAS ANALYSIS.
Description of Event or Problem
THE CUSTOMER REPORTED A DISCREPANT HIGH PH RESULT FROM THEIR EPOC INSTRUMENT COMPARED TO THE RESULTS OBTAINED THREE WEEKS PRIOR FROM A NON-SIEMENS LAB INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.