STATSTRIP GLUCOSE TEST STRIP

Additional Manufacturer Narrative

A DHR REVIEW WAS PERFORMED. NO ABNORMALITIES OR CONCERNS WERE OBSERVED. THE DHR INDICATED THE RELEASED PRODUCT MET ALL SPECIFICATIONS. STATSTRIP GLUCOSE METERS AND TEST STRIPS ARE DESIGNED TO ACCURATELY MEASURE THE GLUCOSE OF WHOLE BLOOD COLLECTED IN HEPARINIZED TUBES OR FRESH CAPILLARY/VENOUS SAMPLES. IT WAS REPORTED THAT THE BLOOD SAMPLES WERE COLLECTED IN A GREY-TOP TUBE CONTAINING SODIUM FLUORIDE, WHICH INHIBITS GLYCOLYSIS AND ALTERS THE SAMPLE CHEMISTRY. THIS CAN INTERFERE WITH THE ELECTROMECHANICAL MEASUREMENT PRINCIPLE OF THE STATSTRIP SYSTEM. PRODUCT IS ANTICIPATED TO RETURN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

THE COMPLAINANT REPORTED SIGNIFICANT DISCREPANCIES BETWEEN LAB VALUES AND THE STATSTRIP XPRESS MEASUREMENT VALUES. UPON ARRIVAL, THE PATIENT WAS SAID TO BE IN AN "UNCONSCIOUS" AND HYPOTHERMIC STATE, BODY TEMPERATURE MEASUREMENT WAS NOT POSSIBLE. THE COMPLAINANT RECOGNIZES THAT THERE IS NO CAUSAL RELATIONSHIP BETWEEN PATIENT'S EXPIRATION AND THE METER RESULTS. TREATMENT FOR PATIENT WAS DELAYED UNTIL LABORATORY REFERENCE VALUE BECAME AVAILABLE. IT WAS REPORTED THAT THE PATIENT EXPIRED SOMETIME LATER.

Additional Manufacturer Narrative

RETURNED NOVA STATSTRIP GLUCOSE TEST STRIPS (LOT # 324260309) MET PERFORMANCE ACCEPTANCE CRITERIA FOR BLOOD SPECIMENS FOR TESTING DONE USING RETURNED AND RETAINED NOVA STATSTRIP GLUCOSE METERS.DISCREPANT VALUES WERE NOT OBTAINED DURING THE TESTING OF THE RETURNED TEST STRIPS AND COULD NOT BE REPRODUCED. ADDITIONALLY, IT WAS NOTED THAT THE BLOOD SAMPLES TAKEN CONTAINED SODIUM FLOURIDE AND WAS NOT TESTED IMMEDIATELY, WHICH INHIBITS GLYCOLYSIS AND ALTERS THE SAMPLE CHEMISTRY. THIS CAN INTERFERE WITH THE ELECTROMECHANICAL MEASUREMEANT PRINCIPLE OF THE STATSTRIP SYSTEM. IT IS CONCLUDED THAT THE TEST STRIPS AND METER DID NOT CONTRIBUTE TO THE DISCREPANT RESULTS. NO FURTHER ACTION IS RECOMMENDED AT THIS TIME. NOVA WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR EVENTS.