STAT PROFILE PRIME PLUS ANALYZER SYSTEM

Additional Manufacturer Narrative

DEVICE INVESTIGATION: A DHR REVIEW WAS PERFORMED BY THE QUALITY CONTROL ENGINEER AND INCLUDED AN ASSESSMENT OF THE PRODUCTION, TESTING, AND RELEASE OF THE ANALYZER. NO ABNORMALITIES OR CONCERNS WERE OBSERVED; THE DHR INDICATED THAT THE RELEASED PRODUCT MET ALL SPECIFICATIONS. THE CUSTOMER DATABASE WAS REVIEWED AND NO ISSUES WERE FOUND. NOVA APPLICATION SPECIALIST WENT ONSITE TO PERFORM CORRELATION TO CUSTOMER'S REFERENCE METHOD. THE CORRELATION DATA DEMONSTRATED THAT THE ANALYZER PERFORMS AS INTENDED. LOCAL DISTRIBUTOR REPRESENTATIVES VISITED THE SITE AND REVIEWED BOTH PATIENT AND QC RESULTS OF THE CONCERNING DAY AND THE FOLLOWING DAYS TOGETHER WITH THE HOSPITAL'S POINT OF CARE (POC) COORDINATOR. ALL QC RESULTS WERE INSIDE THE QC RANGES AND THE PATIENT RESULTS CORRELATED AS EXPECTED TO LAB HEMATOLOGY ANALYZER. DURING SERIES OF VISITS, LOCAL DISTRIBUTOR NOTICED THAT THE SAMPLE HANDLING OF SOME OPERATORS WAS NOT IDEAL. SAMPLES WERE NOT ALWAYS BEING MIXED PRIOR TO ANALYSIS AND CLOT CATCHERS ARE NOT ALWAYS USED. THE ROOT CAUSE FOR HIGH HB AND HCT RESULTS IS DETERMINED TO BE IMPROPER SAMPLE HANDLING. LACK OF HOMOGENEITY OF A BLOOD SAMPLE CAN LEAD TO INCORRECT RESULTS. IMMEDIATE MIXING OF THE SAMPLE UPON BLOOD COLLECTION INSURES THAT THE ANTICOAGULANT IN THE SPECIMEN CONTAINER HAS FULLY DISSOLVED WITH THE BLOOD, THUS MAINTAINING NOT ONLY THE EFFECTIVE ANTICOAGULANT-TO-BLOOD RATIO BUT ALSO PROVIDING A SPECIMEN FREE FROM ANY BLOOD CLOTS. BECAUSE BLOOD CELLS NATURALLY SEDIMENT, A PRIOR THOROUGH MIXING OF THE BLOOD IN THE TUBE IS NECESSARY TO ENSURE ACCURATE READING.

Description of Event or Problem

CUSTOMER REPORTED HIGH HEMOGLOBIN AND HEMATOCRIT PATIENT RESULTS USING NOVA PRIME PLUS ANALYZER WHEN COMPARED TO LAB REFERENCE METHOD. NO HARM OR INAPPROPRIATE TREATMENT WAS REPORTED.