EPOC HOST
Received Dec 10, 2020 · Event occurred Nov 12, 2020
Report 3002637618-2020-00068 · MDR key 10984903
Device
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
Not reported
- Abnormal Blood Gases
- Abnormal Blood Gases
Narrative
Additional Manufacturer Narrative
THE CUSTOMER STATED THAT REPEAT TESTING WAS PERFORMED TO CONFIRM CORRECT RESULTS WHICH MET THE CLINICAL PICTURE AND A CORRECTED REPORT WAS ISSUED. THE POC SPECIALIST OBSERVED HOW THE NURSES WERE RUNNING THE BLOOD GASES ON THE EPOC. MANY OF THE NURSES WERE COLLECTING THE SPECIMEN, THEN PUTTING IT ON ICE. THE CUSTOMER STATED THAT IN THE EPOC MANUAL, THE EPOC IS DESIGNED AS A POINT OF CARE DEVICE, AND THE SAMPLE SHOULD NEVER BE PUT ON ICE. THE MANUAL EXPLAINS THAT ICED SPECIMENS CAN ERRONEOUSLY INCREASE THE PH. THE CUSTOMER STATED THAT THE CORRECTION WAS MADE WITH THE ENTIRE NURSING STAFF AND HAS NOT SEEN THE ISSUE OF DISCREPANT HIGH PH SINCE. THE CUSTOMER IS NOT REQUESTING FURTHER ACTION OR INVESTIGATION AND IS ATTRIBUTING THE ISSUE TO NOT PROPERLY TRAINING THE NURSING STAFF.
Description of Event or Problem
THE CUSTOMER REPORTED DISCREPANT HIGH PH RESULTS ON THE EPOC HOST WHEN COMPARED TO RESULTS ON ANOTHER SIEMENS LAB INSTRUMENT, THE RAPID LAB 1265. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.