STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

Additional Manufacturer Narrative

THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED OR REPRODUCED. THE HOSPITAL CONFIRMED THAT QC AND LINEARITY RESULTS WERE ALL WITHIN THE MANUFACTURER'S RANGE. THE HOSPITAL ALSO CONFIRMED THE PATIENT'S COMPROMISED CIRCULATION. RETAINED NOVA STATSTRIP GLUCOSE TEST STRIPS ALL MET PERFORMANCE ACCEPTANCE CRITERIA WHEN TESTED WITH LINEARITY SOLUTION AS WELL AS WITH BLOOD. PER THE IFU, CAUTION SHOULD BE EXERCISED WHEN TESTING CAPILLARY WHOLE BLOOD DUE TO POTENTIAL PRE-ANALYTICAL VARIABILITY IN CAPILLLARY SPECIMEN COLLECTION. A CAPILLARY WHOLE BLOOD SPECIMEN RELIES UPON AN ADEQUATE, NON-COMPROMISED CAPILLARY BLOOD FLOW. THE HEALTHCARE PROVIDER MUST BE AWARE THAT A CAPILLARY WHOLE BLOOD SPECIMEN GLUCOSE RESULT MAY NOT ALWAYS BE THE SAME AS AN ARTERIAL OR A VENOUS WHOLE BLOOD GLUCOSE RESULT, ESPECIALLY WHEN THE PATIENT'S CONDITION IS RAPIDLY CHANGING. IF A CAPILLARY WHOLE BLOOD GLUCOSE RESULT IS NOT CONSISTENT WITH A PATIENT'S CLINICAL SIGNS AND SYMPTOMS, GLUCOSE TESTING SHOULD BE REPEATED WITH EITHER AN ARTERIAL OR VENOUS SPECIMEN ON THE STATSTRIP GLUCOSE HOSPITAL METER SYSTEM. NO ROOT CAUSE WAS IDENTIFIED AS THE COMPLAINT WAS NOT ABLE TO BE REPRODUCED. A POTENTIAL ROOT CAUSE IS THAT THE PATIENT MIGHT NOT HAVE BEEN A GOOD CANDIDATE FOR FINGERSTICK (CAPILLARY) TESTING DUE TO POOR CIRCULATION. A DHR REVIEW WAS PERFORMED. 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

69 YEAR OLD MALE IN CRITICAL CARE WAS GIVEN 2 AMPS OF DEXTROSE BASED ON CAPILLARY GLUCOSE RESULTS OBTAINED ON THE STATSTRIP GLUCOSE HOSPITAL METER SYSTEM.