It was alleged that there were 16 incidences of false negative hcg results.When comparing, the medline hcg test to home pregnancy tests.It was not indicated if these were associated with different patients or samples.No adverse event nor injuries occurred.Although requested, no further information was provided.
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D9: yes, (b)(6) 2021.H3: yes.Investigation conclusion: retained and returned devices from the reported lot number were tested with qc cut-off standards (25 miu/ml) and high-hcg clinical urine samples (208.5-222.1 iu/ml).The results were read at 3 minutes and all devices yielded the expected positive results.No false negative results were observed during in-house testing.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Manufacturing batch record review did not uncover any relevant non-conformances and found that the lot met quality control specifications.Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.A root cause could not be determined from the available information as the reported issue was not replicated during testing of either retention or returned product.However, case details indicate that the results were read no longer than 3 minutes after the sample was added to the device.Per the package insert, "hold the dropper vertically and transfer 3 full drops of urine (approx.100 microliters) to the specimen well (s) of the test device, and then start the timer; read the result at 3-4 minutes." the result should not be read before or after the appropriate read time.
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