Udi: (b)(4).Initial testing of retained sample of statstrip glucose test strip, lot#: 0319081249 was performed on 24aug2020.A device history record (dhr) review included an assessment of the production, testing, and release of the test strip batch.No abnormalities or concerns were observed and the product lot met specifications upon release.Testing was performed on retained strips, lot#: 0319081249, which met the performance acceptance criteria for linearity solutions and whole blood samples with no discrepant values obtained.Based upon this investigation, it was determined that the incident occurred probably due to use error, not following the proper specimen handling technique for neonatal capillary heel stick sampling (use of heel warmer and proper site preparation).Nova previously performed a comprehensive study on four (4) different lots of statstrip glucose test strips, ages 3, 6, 12, and 18 months.The study evaluated samples with low glucose concentrations and high hematocrit concentrations to simulate venous whole blood neonatal blood specimens.All data met the fda's acceptance criteria.This shows that with proper sample collection and handling the system reports accurate results.Nova is also in the process of revising ifus for the appropriate products to include additional guidance for site preparation and heel stick sample collection for neonates.This effort is being completed via preventive action.The conclusion of the investigation, is that the reported issue, discrepant neonatal glucose results could not be reproduced.No root cause was able to be identified, but based on the information described in the investigation, use error is suspected.Trending will be monitored for this and or similar complaints.
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