As the customer's strips are expired, they cannot be investigated.This test strip lot has been fully investigated.The complained test strips have been calibrated against the who standard and are in scope of the roche initiated recall.For these test strips there is a potential for a product problem when the inr is > 4.5.Values > 4.5 inr showed an increasing positive bias.Investigations have indicated results are reliable from 0.8 to 4.5 inr, since the calibration data covers this measuring range very well.Medwatch field h9 has been updated.
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Request from fda: for 1823260-2020-02077, it is unclear why the event happened in (b)(6) 2018 but reported on 8/24/2020.Response from manufacturer: the event information was first received by roche in july, 2020 through a personal injury attorney for an event that happened in (b)(6) 2018.At this time, we have not received the product back and do not have additional information related to the event.In reviewing the case, we identified an error in the "become aware" date.The report was received by our legal department on july 20, 2020; however, the call agent used july 27, 2020, as the "become aware" date.The report was sent to fda on august 24, 2020.We take our mdr reporting obligations seriously and we have a process to identify the root cause of all late mdrs and to take appropriate actions to prevent recurrence in the future.This appears to have been an error when logging the information into the case handling tool.We will submit a supplemental report if we learn additional information about this event.Medwatch field g4.Has been updated.
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