Medtronic received information that prior to use, during testing, this act plus instrument had unreliable results.The instrument was replaced for the procedure.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that the unreliable results were received with the liquid control.Heparin was not administered based on the test results.
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Device evaluation summary: the reported issue of unreliable results was verified during service.The service technician observed massive dirt and blood residue.The issue was resolved by externally and internally cleaning the instrument.Preventive maintenance was performed per specifications.Note: the device was analyzed in the facility by a field service technician.The device was not returned to a medtronic facility for analysis.Conclusion: the reported issue of unreliable results was verified during service.Medtronic will continue to monitor for future trends and occurrences.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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