A supplemental report is being submitted for device analysis and investigation completion.Product event summary: the controller ((b)(6)) was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Visual inspection revealed contamination within both power ports, the serial port, and the pump connector.Functional testing revealed that the controller was not holding the time/date information.The controller date was 01/01/000 and time was 00:00, indicating an issue with the internal battery that powers the real time clock.Internal inspection did not reveal any anomalies.Supplemental testing revealed that the internal battery, that powers the real time clock circuit, did not provide voltage.These are additional observations not related to the reported event.The most likely root cause of the observed contamination within the controller ports can be attributed to handling of the device.The most likely root cause of the observed real clock time error can be attributed to a faulty internal battery that powers the real clock time circuit.During functional testing, the high priority, medium priority and low priority controller alarms were tested and found to be working/sound as expected.As a result, the reported event could not be confirmed.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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