STATSTRIP HOSPITAL METER SYSTEM

Additional Manufacturer Narrative

ADDITIONAL INFORMATION FROM THE END USER WAS RECEIVED AFTER THE INITIAL COMPLAINT AND CONFIRMED THAT THE PATIENT WAS TREATED GLUCOSE GEL. THE ERRONEOUS RESULTS WERE OBSERVED USING NOVA STATSTRIP GLUCOSE TEST STRIPS (LOT # 0325252249 AND LOT # 0325324249). THIS INVESTIGATION WAS PERFORMED USING RETAINED NOVA STATSTRIP GLUCOSE TEST STRIPS (LOT # 0325253309 AND 0325324249) AND USING RETAINED NOVA STATSTRIP GLUCOSE METERS IN AN EFFORT TO REPRODUCE THE REPORTED RESULTS. IT SHOULD BE NOTED THAT RETAINS OF NOVA STATSTRIP GLUCOSE TEST STRIPS LOT # 0325252249 WERE NOT AVAILABLE FOR TESTING. CONSEQUENTLY, THE SUB LOT # 0325253309 WAS USED IN ITS PLACE. TESTING INCLUDED FIVE (5) LEVELS OF NOVA STATSTRIP GLUCOSE LINEARITY SOLUTION AND 6 (SIX) LEVELS OF WHOLE BLOOD SPECIMENS COLLECTED FROM CONSENTING ADULTS. FIVE (5) NOVA STATSTRIP GLUCOSE METERS WERE USED FOR THE STUDY. FOUR (4) MEASUREMENTS WERE PERFORMED ON EACH METER FOR EACH SAMPLE (20 MEASUREMENTS TOTAL). PLASMA YSI GLUCOSE RESULTS WERE USED AS REFERENCE VALUES FOR THE WHOLE BLOOD SPECIMENS. BOTH LOTS OF RETAINED NOVA STATSTRIP GLUCOSE TEST STRIPS (LOT # 0325253309 AND 0325324249) MEET THE PERFORMANCE ACCEPTANCE CRITERIA FOR LINEARITY SOLUTIONS AND BLOOD SPECIMENS FOR TESTING DONE USING NOVA STATSTRIP GLUCOSE METERS. THERE WERE NO DISCREPANT VALUES OBTAINED DURING THE TESTING. THE LOW RESULTS DESCRIBED IN THE COMPLAINT WERE NOT REPRODUCED. ALTHOUGH A ROOT CAUSE COULD NOT BE CONCLUSIVELY IDENTIFIED, PRE-ANALYTICAL FACTORS WHEN TESTING NEONATES SUCH AS USING AN ADEQUATE SIZE AND TYPE OF LANCET, PROPER HEEL WARMING AND CLEANING, WIPING AWAY THE FIRST BLOOD DROP, AND REFRAINING FROM SQUEEZING OR "MILKING" THE HEEL TO GET BLOOD, COULD BE CONTRIBUTORY FACTORS IN THE DISCREPANT RESULTS. NO FURTHER ACTION IS RECOMMENDED AT THIS TIME. NOVA WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR EVENTS.

Description of Event or Problem

CUSTOMER NOTICED A DISCREPANCY ON A BABY BETWEEN THE METER AND THE LAB ANALYZER.