Medtronic received information that prior to use of these hms plus instruments customer reported both failed the silver cartridge controls recently.Both instruments were serviced recently.Use of instruments is unspecified and there is no adverse patient effect associated with this event.Additional information received from service: medtronic clinical support assisted customer in identifying that instrument was operating ok.Issue identified as telcor data system misinterpreting test results and marking them as failures.When instrument was detecting a clot in channel 4, telcor was interpreting it as channel 2, thus flagging it as a failure.Customer is working with telcor to resolve now.
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Conclusion: complaint not confirmed for the hms plus instruments failing the silver cartridge controls.Per the additional information received from the service team, medtronic clinical support assisted the customer in identifying that instrument was operating ok.The issue was identified as the telcor data system misinterpreting test results and marking them as failures.When the instrument was detecting a clot in the cartridge channel 4, the telecor data system was interpreting it as channel 2, thus flagging it as a failure.The customer is working with telcor to resolve the issue.Trends for issues with this product are reviewed at quarterly quality meetings.This regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa action.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.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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