Internal identifier # 141786-01. This complaint is linked with id# 141909. The initial customer service center investigation and subsequent instrument investigation by a field service representative did not reveal an assignable cause for the complaint. The customer service center has made multiple attempts to acquire info from the customer. However, the customer was not willing to provide the info necessary for a further investigation. Returned goods have not bee received. An assignable cause for this complaint cannot be determined. In every package insert, under limitations of the procedure, a statement is made to evaluate results in conjunction with clinical observations of the pt. A review of the 6/97 trending report, which encompasses 12 months data, was performed for u. S. Complaints against the axsym analyzer. No adverse trends requiring further investigation were found. No corrective action is required. This is the final report.

On 07/31/97 the account reported an erratic phenytoin result of 15mg/l at 8:00 pm, which was run on the axsym analyzer. The sample was run from an aliquot tube. A second aliquot tube from the pt sample. Which was used for thyroid testing the next morning, was also tested for phenytoin and gave a result of 30 mg/l. According to the account, the pt had been released from the hosp after the initial result was reported. No report of injury.