EPOC READER
Received Jul 13, 2022 · Event occurred Jun 14, 2022
Report 3002637618-2022-00040 · MDR key 15007170
Device
Product problems
- Low Test Results
- Low Test Results
Patient
29 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEIR EPOC INSTRUMENT GAVE A DISCREPANT LOW SODIUM RESULT COMPARED TO RETESTING OF THE SAME SAMPLE ON A NON-SIEMENS INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Additional Manufacturer Narrative
SIEMENS HAS REQUESTED INSTRUMENT FILES FOR FURTHER INVESTIGATION HOWEVER THE CUSTOMER DID NOT PROVIDE THEM. THE IN-HOUSE PERFORMANCE OF SODIUM FOR THE CARD LOT IN QUESTION WAS REVIEWED. AQUEOUS FLUIDS AND ARTERIALIZED BLOOD PERFORMED AS EXPECTED AND MET PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE. ADDITIONAL TESTING WAS PERFORMED WITH BLOOD REPRESENTATIVE OF THE CUSTOMER TESTING RANGE. ALL EPOC TEST RESULTS WERE CENTERED WITHIN THE ALLOWABLE TOTAL ERROR AND COMPARABLE TO TEST RESULTS PROVIDED BY OTHER BLOOD GAS ANALYZERS. DIFFERENCES IN INSTRUMENT METHODOLOGIES CANNOT BE RULED OUT AS A ROOT CAUSE OF THE ALLEGED SODIUM DISCREPANCY(IES) AT THE CUSTOMER SITE. THEREFORE, THERE IS NO EVIDENCE THAT THE SYSTEM OR REAGENT CARDS ARE NOT PERFORMING AS INTENDED THE CAUSE OF THIS EVENT IS UNKNOWN.