Other text: this mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.No causes or potential causes of the customer's reported problem were found during the review of service and repair record.The tampered seal label was missing.Scratches and cracks found on liquid crystal display (lcd) lens screen: battery door was missing.No evidence found in the device history log.Device passed the functional tests but failed the three accuracy tests.The device was found to over infuse.The reported problem was not confirmed.However, the device was able to infuse however it was over infusing.The root cause of the reported problem could not be confirmed.However, the technician found other problems.The technician recommended expulsor to be trimmed and replaced the air detector for preventive measure.
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