Manufacturer evaluation: although the device was returned by the complainant, the sample was lost during shipment.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.Although the lot number of the lock was provided, the indicator lot # was not available.Therefore, the device history records (dhr) were not able to be reviewed.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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