The caller (end user) alleged variance between the inratio inr results.Results are as follows: date: (b)(6) 2016, inratio inr: 4.5 and 3.2, time between testing: <5 minutes apart; (b)(6) 2016, 4.6, approximately 3 hours prior to the 1/21/2016 testing; (b)(6) 2016, 2.0 and 3.5, <5 minutes apart.Therapeutic range: 2.5-3.5.There were no changes in the caller's coumadin dose following any of the inratio results.The caller reported that multiple finger sticks were performed on the same finger and the monitor was not in the correct mode when the finger stick was performed.These are considered an improper technique and a user issue when performing the inratio testing.Medical history: cancer and thyroid condition (no recent issues).There was no reported adverse patient sequela.There was no additional information provided.
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Investigation/conclusion: it is indicated that the product is not returning for evaluation.Therefore, a review of the in-house testing history of the strip lot was performed.In-house testing on the reported strip lot met accuracy criteria and the product performed as expected.The manufacturing records for the lot were reviewed and the lot met release specifications.Although the root cause analysis did not include return testing, an improper technique and a user issue was identified in the complaint.These could not be ruled out as a cause of the unexpected results.Based on the information available, there is no indication of a product deficiency and no corrective action is required.
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