Pt reported inaccurately low blood glucose readings with test strips, lot 1j510a. On a unknown date this week, the pt opened the first bottle of test strips from the box and performed a side by side blood glucose comparison using another brand (lot 602889a, code 6, exp. 2/98) versus this brand. He obtained test results of 118 and 24 mg/dl respectively. With the rep. The pt obtained a blood glucose result of 127 mg/dl. With the brand and a result of 32 mg/dl with this brand. The desiccant is in the first bottle from the box. The pt has not opened the second bottle from the same box. The pt has not opened the second bottle from the same box. The pt's meter was set to the appropriate code when all tests were performed. The pt's normal control solution is expired. With the rep, the pt obtained a check strip test result of 77 versus a check strip range of 64-87. The test strips were opened this week.

The retention sample test results for lot 1j510a meet the specs for blood glucose accuracy and precision, and the normal control readings are also within the specified range. Based on the evaluation of retention samples, the risk of product failure in the field is low. Co is unable to determine the cause of the low reading obtained by the customer upon initial opening of the bottle. Container has been determined to meet the requirement for tight container per procedure. Therefore, failure of blood glucose readings could not be due to high rate of moisture premeability of conatainer. Co received the returned product on 3/3/97, and the investigation of the returned product has not been completed. Estimated time to completion is two weeks. Further info will be provided at that time. Is event occurring more frequently than stated in labeling? not stated. Is event ocurring more frequently than is usual for device? no. Is event occurring with greater severity than stated in labeling? not stated. Is event occurring with greater severity than is usual for device? no.