The customer returned co's test strips were received on 3/10/97 and evaluated on 3/13/97. Three bottles with desiccant, two opened (one containing 25 strips and one containing 20 strips) and one unopened (containing 25 strips), were returned for eval. The test results for the opened bottle with 25 strips and unopened bottle met the specifications for blood glucose accuracy and precision. The test results for the opened bottle with 20 strips were below the specification for blood glucose accuracy. Eval of the desiccant inside the returned bottles indicates that failure may be due to exposure to moisture. The source of moisture exposure is unknown. Co is unable to determine the cause of the low readings obtained by customer upon initial opening of both bottles from a display box. Co's container has been determined to meet the requirement for tight container per usp procedure. Therefore, failure of blood glucose readings could not be due to high rate of moisture permeability of co's container. Customer did not perform normal control solution test to check the strips for accuracy. The retention sample test results for lot 1l505b meet the specifications for blood accuracy and precision, and the normal control readings are also within the specified range. Based on the eval of retention samples, the risk of product failure in the field is low. Is event occurring more frequently than stated in labeling? not stated. Is event occurring 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. Submission of the medical device report (mdr) does not constitute an admission that mfr or product caused or contributed to the event or that the information provided is valid.

The pt reported inaccurately low blood glucose readings with 2 bottles of test strips, lot 1l505b. On an unknown date within the last month, the pt opened the first bottle of test strips and performed a side by side blood glucose comparison using co's test strips and another brand test strips (lot 701775a, code 8, exp 1/99). He obtained test results of 101 and 163 mg/dl respectively. Even though he thought the result with co's test strips were low, he continued to use the test strips. Approx three weeks after opening the first bottle, the pt opened the second bottle from the same box and performed a side by side blood glucose comparison (he opened the second bottle because he continued to obtain lower readings with test strips from the first bottle and thought they were not accurate). He obtained a blood glucose test result of 91 mg/dl with the second bottle of co's test strips and a result of 181 mg/dl with the other co's strips. He discontinued use of the first bottle of co's test strips and began to use test strips from the second co's bottle. Some time this week, the pt noticed that his blood glucose readings had decreased to the 30-50 mg/dl range (no specific blood glucose test results available). Because of the lower readings, he performed a blood glucose test using his wife's blood (she is non--diabetic) and obtained a test result of 10 mg/dl (using test strip from second bottle). With the co's rep, the pt obtained a blood glucose test result of 9 mg/dl using co's (second bottle) and his own blood sample. The desiccant is in both co's bottles. The pt's meter was set to the appropriate code when all tests were performed. The pt has 4 other co's bottles (same lot) that he has not opened. Also with the rep, the pt obtained a check strip test result of 89 versus a check strip range of 75-99. The pt's normal control solution is expired.