STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

Additional Manufacturer Narrative

RETAINED NOVA STATSTRIP GLUCOSE TEST STRIPS (LOT# 0324297249) WERE USED FOR THE COMPLAINT INVESTIGATION. TESTING INCLUDED FIVE (5) 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 IN TOTAL). PLASMA YSI GLUCOSE RESULTS WERE USED AS REFERENCE VALUES FOR THE WHOLE BLOOD SPECIMENS.RETAINED NOVA STATSTRIP GLUCOSE TEST STRIPS (LOT # 0324297249) MEET THE PERFORMANCE ACCEPTANCE CRITERIA FOR BLOOD SPECIMENS FOR TESTING DONE USING RETAINED NOVA STATSTRIP GLUCOSE METERS. THERE WERE NO DISCREPANT VALUES OBTAINED DURING THE TESTING OF RETAINED NOVA STATSTRIP GLUCOSE TEST STRIPS (LOT # 0324297249). THE RESULTS DESCRIBED IN THE COMPLAINT WERE NOT REPRODUCED. A DHR REVIEW WAS PERFORMED ON THE REPORTED STRIP LOT. NO ABNORMALITIES OR CONCERNS WERE OBSERVED. THE DHR INDICATED THE RELEASED PRODUCT MET ALL SPECIFICATIONS. NO FURTHER ACTION IS RECOMMENDED AT THIS TIME. NOVA WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR EVENTS.

Description of Event or Problem

"NUMEROUS COMPLAINTS FROM NEWBORN NURSERY REGARDING COMPARISON OF NOVA GLUCOSE METER RESULTS WITH MAIN LABORATORY RESULTS. NOVA CONSISTENTLY TESTING LOWER LEADING TO TREATMENT OF NEWBORN."

Additional Manufacturer Narrative

ATTEMPTS TO OBTAIN SPECIFIC TEST RESULTS HAVE NOT BEEN SUCCESSFUL. INVESTIGATION ANTICIPATED BUT NOT YET BEGUN. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON CONCLUSION OF TESTING. THERE WAS NO REPORTED SEQUELAE AS A RESULT OF THE ADMINISTRATION OF GLUCOSE GEL TO THE NEONATE.