EPOC READER
Received Aug 18, 2020 · Event occurred May 27, 2020
Report 3002637618-2020-00043 · MDR key 10422654
Device
Product problems
- Insufficient Device Problem Information
- Non Reproducible Results
- Insufficient Device Problem Information
- Non Reproducible Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Clinical Signs, Symptoms or Conditions
- No Known Impact Or Consequence To Patient
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER WAS UNABLE TO PROVIDE THE REQUESTED ENCRYPTED TEST RECORDS. A REVIEW OF THE IN-HOUSE PERFORMANCE FOR THE CARD LOT USED, LOT 01-20121-10, DID NOT IDENTIFY ANY PRODUCT DEFICIENCIES. THE FAILURE RATE OF LOT 01-20121-10 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 HAS BEEN ADVISED THAT BLOOD GAS MEASUREMENTS FOR THE PURPOSE OF EVALUATING THE GAS EXCHANGE FUNCTION OF THE LUNGS (PO2 AND PCO2) SHOULD BE PERFORMED ON ARTERIAL BLOOD ONLY. FURTHERMORE, IN CASES WHERE "ARTERIALIZED" CAPILLARY BLOOD MAY BE THE ONLY PRACTICAL ALTERNATIVE TO ARTERIAL BLOOD, THE BLOOD GAS RESULTS SHOULD BE INTERPRETED CAUTIOUSLY.
Additional Manufacturer Narrative
SIEMENS HAS REQUESTED DATA FILES TO BE SENT FOR INVESTIGATION. THE CUSTOMER STATED THAT NO INSTRUMENT DATA IS AVAILABLE. SIEMENS THEN ASKED IF THE ENCRYPTED TEST RECORDS COULD BE EXTRACTED? INSTRUCTIONS HAVE BEEN SENT TO THE CUSTOMER. THESE ARE RESULT FILES THAT REMAIN ON THE HOST AND DOES NOT CROSS OVER TO THE DATA MANAGER. THE CAUSE OF THIS EVENT IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED DISCREPANT PO2 RESULTS ON TWO PATIENTS WHEN TESTED ON THE EPOC READER S/N (B)(4). THE PATIENTS WERE FIRST ANALYZED WITHOUT OXYGEN SUPPLY. THEN THE PATIENTS WERE GIVEN 2L OF OXYGEN FOR 15 MINUTES. THEN THE PATIENTS WERE TESTED AGAIN. THE PHYSICIAN FELT THE RESULTS WERE TOO HIGH AFTER OXYGEN THERAPY DUE TO KNOWING THE PATIENTS HISTORIES. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.