On 9/20/99 the account reported an aeroset glucose of 61 mg/dl. The nurse questioned the result as she had obtained a >400 mg/dl result on a glucometer. The pt was redrawn and rerun with a result of 405 mg/dl. The original sample was then repeated and was 405 mg/dl. The customer stated that the original sample may have had a bubble or fibrin present. The pt was in a coma and the incorrect result delayed treatment by aprroximately 1 hour. No injury reported.

Pt information was sourced by the manufacturer. Glucose result of 61 mg/dl repeated as 405 mg/dl upon redraw. The original tube was re-tested with a result of 405 mg/dl. Instrument precision was evaluated using control material and found to be within label claims. The customer stated that the sample from the original run may have had a bubble or fibrin and that they felt the instrument was operating as required. No additional probable cause was found for the discrepant result. The application sheet for glucose (30-1476/r4/dec98) states that the presence of fibrin may cause erroneous results. The areoset system operations manual (30-1677/r2/march 99, section 7, operational precautions and limitations, specimens - preparation and storage) also states that for optimal results, specimens should be free of fibrin. Adequate labeling exists to minimize any associated risk to pt results. A malfunction did not occur. This is the final report.