EPOC READER
Received Oct 29, 2019 · Event occurred Oct 11, 2019
Report 3002637618-2019-00115 · MDR key 9250108
Device
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
TECH OPS HAS COMPLETED THE INVESTIGATION: A REVIEW OF THE IN-HOUSE PERFORMANCE OF THE CARD LOT IN USE, LOT 00-19168-30, DID NOT IDENTIFY ANY PRODUCT DEFICIENCIES. THE FINISHED GOODS ARTERIALIZED BLOOD RESULTS DID NOT IDENTIFY A PERFORMANCE ISSUE FOR THE HEMOTOCRIT SENSOR OR SPUN HCT, NOR DID THE RESULTS IDENTIFY ANY PERFORMANCE ISSUE WITH CALCULATED HEMOGLOBIN. THEREFORE, WE CONCLUDE THAT THERE IS NO INDICATION OF A FAILURE TO THE PRODUCT. THE FACT THE CUSTOMER CLAIM REPORTS A DISCREPANT HB RESULT OCCURRING ON A SAMPLE WITH 30% HCT INDICATES THAT SOME DEGREE OF HEMODILUTION WAS PRESENT ON THE BLOOD SAMPLE RUN. THE EXACT CAUSE OF THE DISCREPANCY COULD NOT BE DETERMINED, HOWEVER, IN-HOUSE RETAIN TESTING WAS ABLE TO REPLICATE THE OBSERVED EFFECT BY TESTING A HEMODILUTED SAMPLE IN THE ABSENCE OF PROPER ACTIVATION OF THE HEMATOCRIT CORRECTION FACTOR (HCF). FURTHER INQUIRY WITH THE CUSTOMER SHOULD SEEK TO VERIFY THE USE/UNDERSTANDING OF THE HCF WITH RESPECT TO HEMODILUTION. IT IS RECOMMENDED THAT THE CUSTOMER VERIFY IF THE SAMPLE WAS HEMODILUTED WITH A DILUENT ABSENT OF PROTEIN AND IF SO, VERIFY THE USE OF HCF FOR THAT TEST AS DIRECTED BY THE SYSTEM MANUAL. ADDITIONAL SOURCES OF DISCREPANCY WITH THIS SAMPLE COULD RELATE TO SAMPLE HANDLING / PROPER MIXING PRIOR TO TESTING ON THE EPOC DEVICE. IMPROPER MIXING WOULD RESULT IN A LOWER HCT AND A LOWER CHGB.
Additional Manufacturer Narrative
THE CUSTOMER STATED THAT REPEAT TESTING WAS PERFORMED TO CONFIRM CORRECT RESULTS WHICH MATCHED THE PATIENT'S HISTORY AND A CORRECTED REPORT WAS ISSUED. SIEMENS SALES WENT ON SITE AND REVIEWED SAMPLE HANDLING WITH THE CUSTOMER. RELEASE TESTING PERFORMANCE OF THE SAME LOT OF TEST CARDS WILL BE REVIEWED. A RETAIN OF THE TEST CARD WILL BE RUN LOOKING AT THE THB ANALYTE. THE CUSTOMER STATED THEY ARE OPERATIONAL. THE CAUSE OF THIS EVENT IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED DISCREPANT LOW TOTAL HEMOGLOBIN RESULTS ON THE EPOC SYSTEM WHEN COMPARED TO A NON-SIEMENS LAB ANALYZER. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.