(e1) the name of the initial reporter was not provided.Patient was given doses of vitagen (glucose) based on meter results.Patient aministerd vasopressor pitressin and adrenaline while in the er.Capillary sample testing is contraindicated for patients with compromised capillary blood flow.All samples tested on the statstrip glucose hospital meter system were capillary samples.Instruction for use manual: caution: capillary blood glucose testing may not be appropriate for persons with decreased peripheral blood flow, as it may not reflect the true physiological state.Examples include, but are not limited to, sever hypotension, shock, hyperosmolar-hyperglycemia (with or without ketosis) and severe dehydration.Information provided by the hospital indicates the patient condition was 'bad' when sent to the hospital."the doctor thinks the patient passed away not necessarily related to the glucose treatment".The customer complaint could not be confirmed nor replicated.The meter and test strips in question were not returned for evaluation.This is further supported by the confirmation from the hospital that the meter and glucose test strips passed all qc prior to and after the reported incident.The meter system remained in service at the facility.Retained statstrip test strips from the reported lot were test met the performance acceptance criteria for linearity controls and also for whole blood specimens.No discrepant results were observed.A dhr review was performed for the identfied meter and glucose 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 biomedical will continue to monitor for this or similar events.
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