Additional and corrected information: b4, g6, h2, h10 an investigation has been initiated and is currently pending.Further details will be provided in an additional supplemental report when they become available.
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Udi- (b)(4).The customer reported to the fda that, on jan 28, 2021, one lot of statstrip glucose test strips, lot 0320328249, was not working and that an error message came up on the glucometer.After reaching out to the customer for additional information, they reported that the new lot of test strips had been distributed before the lot information was added to nova net.No materials were returned for investigation and no further evaluation was possible.The customer also stated that there was no patient intervention or harm reported.A dhr (device history record) review was performed out of an abundance of caution for the lot of test strips.The review was completed by a quality control engineer and included an assessment of the production, testing, and release of the test strip batch.No abnormalities or concerns were observed; the dhr indicated that the released product met all specifications.A capa (corrective and preventative action) is not required as a result of this investigation because the complaint was not confirmed.The root cause was found to be improper set up of the new lot of test strips in novanet as reported by the customer.This is attributed to user error and does not identify any issue with the nova product.Nova will continue to monitor for recurrence, no further action is required at this time.
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